"biosimilar" - Google News

Samsung Bioepis Launches OPUVIZ Biosimilar in Europe - Contract Pharma

Fri, 29 May 2026 13:16:55 GMT

Samsung Bioepis Launches OPUVIZ Biosimilar in Europe Contract Pharma

Biosimilar Adoption and Provider Performance in Medicare Value-Based Payment Models - AJMC

Tue, 05 May 2026 07:00:00 GMT

Comments on biosimilar streamlining efforts and context on commercial barriers to competition - Brookings

Thu, 07 May 2026 07:00:00 GMT

Comments on biosimilar streamlining efforts and context on commercial barriers to competition Brookings

FDA Issues Draft Guidance Aimed at Cutting Expenses for Biosimilar PK Studies - Center for Biosimilars

Mon, 09 Mar 2026 07:00:00 GMT

FDA Issues Draft Guidance Aimed at Cutting Expenses for Biosimilar PK Studies Center for Biosimilars

FDA proposes to ease testing rules to speed up biosimilar drug development - Reuters

Mon, 09 Mar 2026 07:00:00 GMT

FDA proposes to ease testing rules to speed up biosimilar drug development Reuters

Samsung Bioepis launches Opuviz across Europe - The Pharma Letter

Fri, 29 May 2026 13:29:17 GMT

Samsung Bioepis launches Opuviz across Europe The Pharma Letter

CVS to expand biosimilar formulary adoptions to improve affordability, accessibility - Fierce Healthcare

Tue, 05 May 2026 07:00:00 GMT

CVS to expand biosimilar formulary adoptions to improve affordability, accessibility Fierce Healthcare

FDA unveils 4th revision of draft guidance for looser biosimilar testing requirements - Fierce Pharma

Mon, 09 Mar 2026 07:00:00 GMT

FDA unveils 4th revision of draft guidance for looser biosimilar testing requirements Fierce Pharma

New FDA guidance could elevate pharma’s biosimilar market - BioPharma Dive

Fri, 13 Mar 2026 07:00:00 GMT

New FDA guidance could elevate pharma’s biosimilar market BioPharma Dive

FDA Moves to Streamline Biosimilar Development: The Implications for Regulatory and IP Strategy - Skadden, Arps, Slate, Meagher & Flom LLP

Mon, 16 Mar 2026 07:00:00 GMT

FDA Moves to Streamline Biosimilar Development: The Implications for Regulatory and IP Strategy Skadden, Arps, Slate, Meagher & Flom LLP

FDA Releases Updated Guidance on Biosimilar Development - The ASCO Post

Tue, 10 Mar 2026 07:00:00 GMT

FDA Releases Updated Guidance on Biosimilar Development The ASCO Post

FDA proposes major change to biosimilar PK study requirements - RAPS.org

Mon, 09 Mar 2026 07:00:00 GMT

FDA proposes major change to biosimilar PK study requirements RAPS.org

Samsung Bioepis Launches OPUVIZ (Aflibercept) 40 mg/mL Vial Across Europe, to Treat Ophthalmic Conditions - Business Wire

Fri, 29 May 2026 06:00:00 GMT

Samsung Bioepis Launches OPUVIZ (Aflibercept) 40 mg/mL Vial Across Europe, to Treat Ophthalmic Conditions Business Wire

Over Three Dozen Groups Join the Biosimilars Council and AAM to Reiterate Support for Interchangeability Legislation - Association for Accessible Medicines

Thu, 22 Jan 2026 19:18:40 GMT

Over Three Dozen Groups Join the Biosimilars Council and AAM to Reiterate Support for Interchangeability Legislation Association for Accessible Medicines

FDA's Biosimilar Playbook: Merging Biosimilarity with Interchangeability - Jones Day

Wed, 03 Dec 2025 20:33:45 GMT

FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma's Biosimilar to NEUPOGEN® (filgrastim) - PR Newswire

Tue, 17 Feb 2026 08:00:00 GMT

FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma's Biosimilar to NEUPOGEN® (filgrastim) PR Newswire

Biosimilar Therapeutics Substitution - Neurology® Journals

Tue, 13 Jan 2026 08:00:00 GMT

Biosimilar Therapeutics Substitution Neurology® Journals

FDA Plans to Loosen Testing Rules to Boost Biosimilar Drugs - Bloomberg.com

Mon, 09 Mar 2026 07:00:00 GMT

FDA Plans to Loosen Testing Rules to Boost Biosimilar Drugs Bloomberg.com

AAM and Biosimilars Council Laud FDA Plan to Streamline Biosimilar Medicines Development and Lower Costs for Patients - Association for Accessible Medicines

Tue, 10 Mar 2026 07:00:00 GMT

2025 U.S. Generic & Biosimilar Medicines Savings Report - Association for Accessible Medicines

Thu, 04 Sep 2025 06:22:41 GMT

2025 U.S. Generic & Biosimilar Medicines Savings Report Association for Accessible Medicines

Global Biosimilar Market Sees Structural Shifts, Regulatory Hurdles, and Pipeline Gains - Center for Biosimilars

Tue, 10 Mar 2026 07:00:00 GMT

Sandoz creates new global biosimilar development, manufacturing and supply unit, appoints industry veteran Armin Metzger to lead next phase of growth - Sandoz

Tue, 10 Mar 2026 06:59:11 GMT

Sandoz creates new global biosimilar development, manufacturing and supply unit, appoints industry veteran Armin Metzger to lead next phase of growth Sandoz

FDA Approves New Interchangeable Biosimilar of Insulin Glargine, Expanding Substitution Authority for Pharmacists - Pharmacy Times

Mon, 04 May 2026 07:00:00 GMT

FDA Approves New Interchangeable Biosimilar of Insulin Glargine, Expanding Substitution Authority for Pharmacists Pharmacy Times

From Promise to Proof: The Shakeup in Today’s Biosimilar Market - Pharmaceutical Commerce

Tue, 19 May 2026 13:15:53 GMT

From Promise to Proof: The Shakeup in Today’s Biosimilar Market Pharmaceutical Commerce

FDA Guidance to Remove One of the Largest Barriers to Biosimilar Development - AJMC

Wed, 29 Oct 2025 07:00:00 GMT

FDA Guidance to Remove One of the Largest Barriers to Biosimilar Development AJMC

FDA Policy Changes Could Bring Some Biosimilars to Market Faster - Skadden, Arps, Slate, Meagher & Flom LLP

Tue, 04 Nov 2025 08:00:00 GMT

FDA Policy Changes Could Bring Some Biosimilars to Market Faster Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s Plan To Boost Biosimilar Drugs Could Stall at the Patent Office - KFF Health News

Mon, 17 Nov 2025 08:00:00 GMT

FDA’s Plan To Boost Biosimilar Drugs Could Stall at the Patent Office KFF Health News

A Closer Look at New FDA Guidance Removing Barriers to Biosimilar Development - Center for Biosimilars

Thu, 30 Oct 2025 07:00:00 GMT

A Closer Look at New FDA Guidance Removing Barriers to Biosimilar Development Center for Biosimilars

BioRationality: The FDA Sets Sights on Removing Clinical Efficacy Studies for Biosimilars - Center for Biosimilars

Wed, 29 Oct 2025 07:00:00 GMT

BioRationality: The FDA Sets Sights on Removing Clinical Efficacy Studies for Biosimilars Center for Biosimilars

FDA Approves Amneal Denosumab Biosimilars, Capping Year of Market Expansion - Center for Biosimilars

Tue, 06 Jan 2026 08:00:00 GMT

FDA Approves Amneal Denosumab Biosimilars, Capping Year of Market Expansion Center for Biosimilars

FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design - Wilson Sonsini

Thu, 13 Nov 2025 08:00:00 GMT

FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design Wilson Sonsini

AAM and the Biosimilars Council Applaud FDA Announcement on Biosimilars Clinical Efficacy Studies and Interchangeability - Association for Accessible Medicines

Wed, 29 Oct 2025 07:00:00 GMT

AAM and the Biosimilars Council Applaud FDA Announcement on Biosimilars Clinical Efficacy Studies and Interchangeability Association for Accessible Medicines

Sandoz to set up standalone biosimilars unit as it eyes upcoming 'golden decade' of patent losses - Fierce Pharma

Tue, 10 Mar 2026 07:00:00 GMT

Sandoz to set up standalone biosimilars unit as it eyes upcoming 'golden decade' of patent losses Fierce Pharma

Provider Perspectives on Biosimilars Amid an Evolving Market - Dermatology Advisor

Fri, 31 Oct 2025 07:00:00 GMT

Provider Perspectives on Biosimilars Amid an Evolving Market Dermatology Advisor

As biosim industry confronts looming 'void,' 2026 marks a chance to take stock and embrace changing landscape - Fierce Pharma

Thu, 08 Jan 2026 08:00:00 GMT

As biosim industry confronts looming 'void,' 2026 marks a chance to take stock and embrace changing landscape Fierce Pharma

Generic and Biosimilar Medicines Save $467 Billion in 2024 - Association for Accessible Medicines

Wed, 03 Sep 2025 07:00:00 GMT

Generic and Biosimilar Medicines Save $467 Billion in 2024 Association for Accessible Medicines

Euro Roundup: EMA finalizes reflection paper on biosimilar comparative efficacy studies - RAPS.org

Thu, 02 Apr 2026 07:00:00 GMT

Euro Roundup: EMA finalizes reflection paper on biosimilar comparative efficacy studies RAPS.org

Rep. Pfluger Introduces Bill to Lower Prescription Drug Prices for Texans - Congressman August Pfluger (.gov)

Fri, 19 Sep 2025 07:00:00 GMT

Rep. Pfluger Introduces Bill to Lower Prescription Drug Prices for Texans Congressman August Pfluger (.gov)

Biosimilar drugs will no longer need phase 3 clinical trials: Proposed changes from Health Canada - Norton Rose Fulbright

Sun, 15 Mar 2026 07:08:50 GMT

What It Takes to Grow the Generic and Biosimilar Pipeline - The American Action Forum

Fri, 13 Feb 2026 08:00:00 GMT

What It Takes to Grow the Generic and Biosimilar Pipeline The American Action Forum

FDA homes in on biosimilar accessibility in new draft guidance - Pharmaceutical Technology

Tue, 10 Mar 2026 07:00:00 GMT

FDA homes in on biosimilar accessibility in new draft guidance Pharmaceutical Technology

Samsung Bioepis reaches settlement agreement for Eylea (aflibercept) biosimilar - Ophthalmology Times

Tue, 17 Feb 2026 08:00:00 GMT

Samsung Bioepis reaches settlement agreement for Eylea (aflibercept) biosimilar Ophthalmology Times

Biosimilar drugs: Phase 3 clinical trials no longer required for approval in Canada - Norton Rose Fulbright

Tue, 19 May 2026 07:00:00 GMT

BioRationality: Entering a New Era of Affordable Biosimilar Development - Center for Biosimilars

Tue, 23 Dec 2025 08:00:00 GMT

BioRationality: Entering a New Era of Affordable Biosimilar Development Center for Biosimilars

Hospitals increased oncology biosimilars use and secured greater margins along the way - Fierce Healthcare

Mon, 16 Mar 2026 07:00:00 GMT

Hospitals increased oncology biosimilars use and secured greater margins along the way Fierce Healthcare

Biosimilar CT-P43 Matches Ustekinumab in Treating Moderate to Severe Plaque Psoriasis - AJMC

Thu, 19 Mar 2026 07:00:00 GMT

FDA Reveals New Guidance for Streamlining Biosimilar Development - PharmExec.com

Wed, 11 Mar 2026 07:00:00 GMT

FDA Reveals New Guidance for Streamlining Biosimilar Development PharmExec.com

This Week’s Biopharma News: EU Clears First Pertuzumab Biosimilar - The Medicine Maker

Tue, 05 May 2026 07:00:00 GMT

This Week’s Biopharma News: EU Clears First Pertuzumab Biosimilar The Medicine Maker

Golimumab Biosimilar Matches Reference Drug in Year-Long RA Trial - Center for Biosimilars

Thu, 19 Mar 2026 07:00:00 GMT

Golimumab Biosimilar Matches Reference Drug in Year-Long RA Trial Center for Biosimilars

FDA Proposes to Remove Comparative Efficacy Studies to Accelerate Biosimilar Development - Jones Day

Tue, 04 Nov 2025 12:40:26 GMT

FDA Proposes to Remove Comparative Efficacy Studies to Accelerate Biosimilar Development Jones Day

PONLIMSI Biosimilar Approval and Xolair Filings Could Be A Game Changer For Teva Pharmaceutical Industries (TEVA) - Yahoo Finance

Wed, 01 Apr 2026 07:00:00 GMT

The Stelara Biosimilar Price War: How PBM-Affiliated Private Labels Are Reshaping the Market (rerun) - Drug Channels

Tue, 07 Oct 2025 07:00:00 GMT

The Stelara Biosimilar Price War: How PBM-Affiliated Private Labels Are Reshaping the Market (rerun) Drug Channels

FDA Approves Teva Biosimilar for Denosumab in Osteoporosis - Center for Biosimilars

Tue, 31 Mar 2026 07:00:00 GMT

FDA Approves Teva Biosimilar for Denosumab in Osteoporosis Center for Biosimilars

Mark Cuban is trying to shake up biosimilar pricing with a version of J&J's best-selling Stelara drug - statnews.com

Thu, 06 Nov 2025 08:00:00 GMT

Mark Cuban is trying to shake up biosimilar pricing with a version of J&J's best-selling Stelara drug statnews.com

U.S. Biosimilar Market Entry Challenges and Facilitating Factors - HHS.gov

Fri, 29 Aug 2025 07:00:00 GMT

Unintended Consequences: Biosimilar Reimbursement Policies and Their Impact on Sustainability - Specialty Pharmacy Continuum

Fri, 20 Feb 2026 08:00:00 GMT

Unintended Consequences: Biosimilar Reimbursement Policies and Their Impact on Sustainability Specialty Pharmacy Continuum

IQVIA Data Show Uneven Biosimilar Uptake Across Drug Classes - Pharmacy Practice News

Thu, 19 Feb 2026 08:00:00 GMT

IQVIA Data Show Uneven Biosimilar Uptake Across Drug Classes Pharmacy Practice News

Top 5 Most-Read Biosimilar News of 2025 - Center for Biosimilars

Wed, 31 Dec 2025 08:00:00 GMT

Top 5 Most-Read Biosimilar News of 2025 Center for Biosimilars

Italian Competition Authority opens investigation into Biogen over alleged abuse of dominance in multiple sclerosis drug market - leadersleague.com

Fri, 29 May 2026 16:22:26 GMT

Italian Competition Authority opens investigation into Biogen over alleged abuse of dominance in multiple sclerosis drug market leadersleague.com

“Gainsharing” methods of payment can boost use of biosimilars, a less expensive cancer treatment - UC Berkeley School of Public Health

Mon, 16 Mar 2026 07:00:00 GMT

“Gainsharing” methods of payment can boost use of biosimilars, a less expensive cancer treatment UC Berkeley School of Public Health

Teva Intensifies Biosimilar Competition with FDA Approval and Dual Filing Acceptance in US and Europe - BioPharm International

Wed, 01 Apr 2026 07:00:00 GMT

Teva Intensifies Biosimilar Competition with FDA Approval and Dual Filing Acceptance in US and Europe BioPharm International

What Australia’s Experience Reveals About Biosimilar Adoption and Pricing - Center for Biosimilars

Thu, 15 Jan 2026 08:00:00 GMT

What Australia’s Experience Reveals About Biosimilar Adoption and Pricing Center for Biosimilars

Bridging the Gap in Biosimilar Use And Uptake in Inflammatory Conditions - Specialty Pharmacy Continuum

Tue, 24 Feb 2026 08:00:00 GMT

Bridging the Gap in Biosimilar Use And Uptake in Inflammatory Conditions Specialty Pharmacy Continuum

What Non-Pricing Factors Are Impacting Biosimilar Decision Making - PharmExec.com

Thu, 16 Apr 2026 07:00:00 GMT

What Non-Pricing Factors Are Impacting Biosimilar Decision Making PharmExec.com

Amneal inks $1.1B Kashiv buyout to pursue biosimilar market leadership - BioSpace

Thu, 23 Apr 2026 07:00:00 GMT

Amneal inks $1.1B Kashiv buyout to pursue biosimilar market leadership BioSpace

FDA Moves to Streamline Approach to Biosimilars - Latham & Watkins LLP

Mon, 10 Nov 2025 08:00:00 GMT

FDA Moves to Streamline Approach to Biosimilars Latham & Watkins LLP

Platinum-Standard Science: FDA’s New Streamlined Framework for Biosimilars and Interchangeability - Paragon Health Institute

Mon, 22 Dec 2025 08:00:00 GMT

Platinum-Standard Science: FDA’s New Streamlined Framework for Biosimilars and Interchangeability Paragon Health Institute

Evidence Gaps Continue to Shape Biosimilar Adoption in Pediatric Care - Center for Biosimilars

Mon, 05 Jan 2026 08:00:00 GMT

Evidence Gaps Continue to Shape Biosimilar Adoption in Pediatric Care Center for Biosimilars

This Week’s Biopharma News: ADCs, Biosimilars, and Microbiome Moves - The Medicine Maker

Tue, 26 May 2026 08:39:33 GMT

This Week’s Biopharma News: ADCs, Biosimilars, and Microbiome Moves The Medicine Maker

Omalizumab Biosimilar Entry Linked to Expanded Patient Access, Reduced Spending - Center for Biosimilars

Thu, 26 Feb 2026 08:00:00 GMT

Omalizumab Biosimilar Entry Linked to Expanded Patient Access, Reduced Spending Center for Biosimilars

FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job - Center for Biosimilars

Mon, 26 Jan 2026 08:00:00 GMT

FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job Center for Biosimilars

FDA proposes scrapping some in-human biosimilar studies - FirstWord Pharma

Wed, 29 Oct 2025 07:00:00 GMT

FDA proposes scrapping some in-human biosimilar studies FirstWord Pharma

FDA Moves to Streamline Biosimilar Development: The Implications for Regulatory and IP Strategy - JD Supra

Mon, 16 Mar 2026 07:00:00 GMT

FDA Moves to Streamline Biosimilar Development: The Implications for Regulatory and IP Strategy JD Supra

FDA, aiming to lower drug costs, moves to speed approval of biosimilars - BioPharma Dive

Wed, 29 Oct 2025 07:00:00 GMT

FDA, aiming to lower drug costs, moves to speed approval of biosimilars BioPharma Dive

US and EU perspectives on the evolving nature of clinical requirements for biosimilars - www.hoganlovells.com

Fri, 26 Sep 2025 07:00:00 GMT

US and EU perspectives on the evolving nature of clinical requirements for biosimilars www.hoganlovells.com

WATCH: Health Secretary RFK Jr. announces new FDA move to fast-track biosimilar drug approvals - PBS

Wed, 29 Oct 2025 07:00:00 GMT

WATCH: Health Secretary RFK Jr. announces new FDA move to fast-track biosimilar drug approvals PBS

Pharmalot: We're reading about a lack of FDA adcomms, FDA loosening biosimilar rules, and more - statnews.com

Mon, 09 Mar 2026 07:00:00 GMT

Pharmalot: We're reading about a lack of FDA adcomms, FDA loosening biosimilar rules, and more statnews.com

AMGN Stock Down 13% in 3 Months: Buy the Dip or Book Profits? - TradingView

Tue, 26 May 2026 13:21:00 GMT

AMGN Stock Down 13% in 3 Months: Buy the Dip or Book Profits? TradingView

Samsung Bioepis Releases Second Quarter 2026 US Biosimilar Market Report - Business Wire

Mon, 27 Apr 2026 07:00:00 GMT

Samsung Bioepis Releases Second Quarter 2026 US Biosimilar Market Report Business Wire

Real-world effectiveness and safety of ranibizumab biosimilar FYB-201 in Saudi Arabia (Ravegza) and Jordan (Uptera): a middle eastern extension of the FORCE study - Nature

Sat, 16 May 2026 07:00:00 GMT

Real-world effectiveness and safety of ranibizumab biosimilar FYB-201 in Saudi Arabia (Ravegza) and Jordan (Uptera): a middle eastern extension of the FORCE study Nature

Don’t hinder biosimilar development - Competitive Enterprise Institute

Thu, 30 Apr 2026 07:00:00 GMT

Don’t hinder biosimilar development Competitive Enterprise Institute

FDA to streamline approvals for generic biological drugs in latest move targeting health costs - CNN

Wed, 29 Oct 2025 07:00:00 GMT

FDA to streamline approvals for generic biological drugs in latest move targeting health costs CNN

Retrospective Study: Rituximab Biosimilar Treats Membranous Nephropathy - Bioengineer.org

Fri, 29 May 2026 10:11:51 GMT

Retrospective Study: Rituximab Biosimilar Treats Membranous Nephropathy Bioengineer.org

Biosimilar Drug Poses New Test for Medicare Price Negotiations - Bloomberg Law News

Thu, 12 Feb 2026 08:00:00 GMT

US proposal to halve biosimilar development costs for India's Biocon, top exec says - Reuters

Thu, 13 Nov 2025 08:00:00 GMT

US proposal to halve biosimilar development costs for India's Biocon, top exec says Reuters

FDA Proposes To Eliminate Comparative Clinical Efficiency Studies for Biosimilars - Arnold & Porter

Mon, 03 Nov 2025 08:00:00 GMT

FDA Proposes To Eliminate Comparative Clinical Efficiency Studies for Biosimilars Arnold & Porter

Biosimilar Competition Linked to Lower Out-of-Pocket Costs for Medicare Patients - Center for Biosimilars

Wed, 21 Jan 2026 08:00:00 GMT

FDA Approves Nufymco, Interchangeable Ranibizumab Biosimilar, for Retinal Diseases - Pharmacy Times

Tue, 23 Dec 2025 08:00:00 GMT

FDA Approves Nufymco, Interchangeable Ranibizumab Biosimilar, for Retinal Diseases Pharmacy Times

Rapid increase in Humira biosimilar orders after CVS formulary change not sustained - Healio

Mon, 06 Apr 2026 07:00:00 GMT

Rapid increase in Humira biosimilar orders after CVS formulary change not sustained Healio

FDA Approves Novel Interchangeable Biosimilar for Pertuzumab in HER2+ Breast Cancer - Targeted Oncology

Thu, 13 Nov 2025 08:00:00 GMT

FDA Approves Novel Interchangeable Biosimilar for Pertuzumab in HER2+ Breast Cancer Targeted Oncology

SBR issues position statement on safe originator biological/biosimilar interchangeability - Generics and Biosimilars Initiative

Fri, 13 Mar 2026 11:33:00 GMT

SBR issues position statement on safe originator biological/biosimilar interchangeability Generics and Biosimilars Initiative

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline - Updated January 22, 2026 - JD Supra

Thu, 22 Jan 2026 08:00:00 GMT

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline - Updated January 22, 2026 JD Supra

Webinar: Aligning Biosimilar Access Policy With Global Health Priorities - Center for Biosimilars

Fri, 14 Nov 2025 08:00:00 GMT

Webinar: Aligning Biosimilar Access Policy With Global Health Priorities Center for Biosimilars

Trial Data Support Equivalence of Denosumab Biosimilar in Postmenopausal Osteoporosis - Center for Biosimilars

Fri, 16 Jan 2026 08:00:00 GMT

Trial Data Support Equivalence of Denosumab Biosimilar in Postmenopausal Osteoporosis Center for Biosimilars

Blue Cross Blue Shield of Michigan Biosimilar Program Saves Members, Customers Over 90% on Specialty Drugs in 2025 - Detroit Regional Chamber

Wed, 06 May 2026 01:53:06 GMT

Blue Cross Blue Shield of Michigan Biosimilar Program Saves Members, Customers Over 90% on Specialty Drugs in 2025 Detroit Regional Chamber

Sandoz signs global license agreement to commercialize breast cancer biosimilar pertuzumab - Sandoz

Wed, 12 Nov 2025 08:00:00 GMT

Sandoz signs global license agreement to commercialize breast cancer biosimilar pertuzumab Sandoz

Perceptions Still Play a Central Role in Biosimilar Insulin Switching - Center for Biosimilars

Tue, 20 Jan 2026 08:00:00 GMT

Perceptions Still Play a Central Role in Biosimilar Insulin Switching Center for Biosimilars

What are biologics and can the Trump administration make them cheaper with biosimilars? - PBS

Wed, 19 Nov 2025 08:00:00 GMT

What are biologics and can the Trump administration make them cheaper with biosimilars? PBS

New U.S. biosimilar launches of top products 2024-2029 - Statista

Thu, 19 Feb 2026 08:00:00 GMT

"biosimilar" - Google News

Samsung Bioepis Launches OPUVIZ Biosimilar in Europe - Contract Pharma

Biosimilar Adoption and Provider Performance in Medicare Value-Based Payment Models - AJMC

Comments on biosimilar streamlining efforts and context on commercial barriers to competition - Brookings

FDA Issues Draft Guidance Aimed at Cutting Expenses for Biosimilar PK Studies - Center for Biosimilars

FDA proposes to ease testing rules to speed up biosimilar drug development - Reuters

Samsung Bioepis launches Opuviz across Europe - The Pharma Letter

CVS to expand biosimilar formulary adoptions to improve affordability, accessibility - Fierce Healthcare

FDA unveils 4th revision of draft guidance for looser biosimilar testing requirements - Fierce Pharma

New FDA guidance could elevate pharma’s biosimilar market - BioPharma Dive

FDA Moves to Streamline Biosimilar Development: The Implications for Regulatory and IP Strategy - Skadden, Arps, Slate, Meagher & Flom LLP

FDA Releases Updated Guidance on Biosimilar Development - The ASCO Post

FDA proposes major change to biosimilar PK study requirements - RAPS.org

Samsung Bioepis Launches OPUVIZ (Aflibercept) 40 mg/mL Vial Across Europe, to Treat Ophthalmic Conditions - Business Wire

Over Three Dozen Groups Join the Biosimilars Council and AAM to Reiterate Support for Interchangeability Legislation - Association for Accessible Medicines

FDA's Biosimilar Playbook: Merging Biosimilarity with Interchangeability - Jones Day

FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma's Biosimilar to NEUPOGEN® (filgrastim) - PR Newswire

Biosimilar Therapeutics Substitution - Neurology® Journals

FDA Plans to Loosen Testing Rules to Boost Biosimilar Drugs - Bloomberg.com

AAM and Biosimilars Council Laud FDA Plan to Streamline Biosimilar Medicines Development and Lower Costs for Patients - Association for Accessible Medicines

2025 U.S. Generic & Biosimilar Medicines Savings Report - Association for Accessible Medicines

Global Biosimilar Market Sees Structural Shifts, Regulatory Hurdles, and Pipeline Gains - Center for Biosimilars

Sandoz creates new global biosimilar development, manufacturing and supply unit, appoints industry veteran Armin Metzger to lead next phase of growth - Sandoz

FDA Approves New Interchangeable Biosimilar of Insulin Glargine, Expanding Substitution Authority for Pharmacists - Pharmacy Times

From Promise to Proof: The Shakeup in Today’s Biosimilar Market - Pharmaceutical Commerce

FDA Guidance to Remove One of the Largest Barriers to Biosimilar Development - AJMC

FDA Policy Changes Could Bring Some Biosimilars to Market Faster - Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s Plan To Boost Biosimilar Drugs Could Stall at the Patent Office - KFF Health News

A Closer Look at New FDA Guidance Removing Barriers to Biosimilar Development - Center for Biosimilars

BioRationality: The FDA Sets Sights on Removing Clinical Efficacy Studies for Biosimilars - Center for Biosimilars

FDA Approves Amneal Denosumab Biosimilars, Capping Year of Market Expansion - Center for Biosimilars

FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design - Wilson Sonsini

AAM and the Biosimilars Council Applaud FDA Announcement on Biosimilars Clinical Efficacy Studies and Interchangeability - Association for Accessible Medicines

Sandoz to set up standalone biosimilars unit as it eyes upcoming 'golden decade' of patent losses - Fierce Pharma

Provider Perspectives on Biosimilars Amid an Evolving Market - Dermatology Advisor

As biosim industry confronts looming 'void,' 2026 marks a chance to take stock and embrace changing landscape - Fierce Pharma

Generic and Biosimilar Medicines Save $467 Billion in 2024 - Association for Accessible Medicines

Euro Roundup: EMA finalizes reflection paper on biosimilar comparative efficacy studies - RAPS.org

Rep. Pfluger Introduces Bill to Lower Prescription Drug Prices for Texans - Congressman August Pfluger (.gov)

Biosimilar drugs will no longer need phase 3 clinical trials: Proposed changes from Health Canada - Norton Rose Fulbright

What It Takes to Grow the Generic and Biosimilar Pipeline - The American Action Forum

FDA homes in on biosimilar accessibility in new draft guidance - Pharmaceutical Technology

Samsung Bioepis reaches settlement agreement for Eylea (aflibercept) biosimilar - Ophthalmology Times

Biosimilar drugs: Phase 3 clinical trials no longer required for approval in Canada - Norton Rose Fulbright

BioRationality: Entering a New Era of Affordable Biosimilar Development - Center for Biosimilars

SPONSORED Biosimilars, the healthcare hero in danger - Axios

Hospitals increased oncology biosimilars use and secured greater margins along the way - Fierce Healthcare

Biosimilar CT-P43 Matches Ustekinumab in Treating Moderate to Severe Plaque Psoriasis - AJMC

FDA Reveals New Guidance for Streamlining Biosimilar Development - PharmExec.com

This Week’s Biopharma News: EU Clears First Pertuzumab Biosimilar - The Medicine Maker

Golimumab Biosimilar Matches Reference Drug in Year-Long RA Trial - Center for Biosimilars

FDA Proposes to Remove Comparative Efficacy Studies to Accelerate Biosimilar Development - Jones Day

PONLIMSI Biosimilar Approval and Xolair Filings Could Be A Game Changer For Teva Pharmaceutical Industries (TEVA) - Yahoo Finance

The Stelara Biosimilar Price War: How PBM-Affiliated Private Labels Are Reshaping the Market (rerun) - Drug Channels

FDA Approves Teva Biosimilar for Denosumab in Osteoporosis - Center for Biosimilars

Mark Cuban is trying to shake up biosimilar pricing with a version of J&J's best-selling Stelara drug - statnews.com

U.S. Biosimilar Market Entry Challenges and Facilitating Factors - HHS.gov

Unintended Consequences: Biosimilar Reimbursement Policies and Their Impact on Sustainability - Specialty Pharmacy Continuum

IQVIA Data Show Uneven Biosimilar Uptake Across Drug Classes - Pharmacy Practice News

Top 5 Most-Read Biosimilar News of 2025 - Center for Biosimilars

Italian Competition Authority opens investigation into Biogen over alleged abuse of dominance in multiple sclerosis drug market - leadersleague.com

“Gainsharing” methods of payment can boost use of biosimilars, a less expensive cancer treatment - UC Berkeley School of Public Health

Teva Intensifies Biosimilar Competition with FDA Approval and Dual Filing Acceptance in US and Europe - BioPharm International

What Australia’s Experience Reveals About Biosimilar Adoption and Pricing - Center for Biosimilars

Bridging the Gap in Biosimilar Use And Uptake in Inflammatory Conditions - Specialty Pharmacy Continuum

What Non-Pricing Factors Are Impacting Biosimilar Decision Making - PharmExec.com

Amneal inks $1.1B Kashiv buyout to pursue biosimilar market leadership - BioSpace

FDA Moves to Streamline Approach to Biosimilars - Latham & Watkins LLP

Platinum-Standard Science: FDA’s New Streamlined Framework for Biosimilars and Interchangeability - Paragon Health Institute

Evidence Gaps Continue to Shape Biosimilar Adoption in Pediatric Care - Center for Biosimilars

This Week’s Biopharma News: ADCs, Biosimilars, and Microbiome Moves - The Medicine Maker

Omalizumab Biosimilar Entry Linked to Expanded Patient Access, Reduced Spending - Center for Biosimilars

FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job - Center for Biosimilars

FDA proposes scrapping some in-human biosimilar studies - FirstWord Pharma

FDA Moves to Streamline Biosimilar Development: The Implications for Regulatory and IP Strategy - JD Supra

FDA, aiming to lower drug costs, moves to speed approval of biosimilars - BioPharma Dive

US and EU perspectives on the evolving nature of clinical requirements for biosimilars - www.hoganlovells.com

WATCH: Health Secretary RFK Jr. announces new FDA move to fast-track biosimilar drug approvals - PBS

Pharmalot: We're reading about a lack of FDA adcomms, FDA loosening biosimilar rules, and more - statnews.com

AMGN Stock Down 13% in 3 Months: Buy the Dip or Book Profits? - TradingView