Biosimilars from Elsevier Business Intelligence

Biosimilars: Exclusivity Guidance Possible; Head-To-Head Comparison Studies Sinking In

Mon, 28 May 2012 00:00:00 -0400

FDA’s Denise Esposito says that in many cases the agency will require biosimilar sponsors to conduct head-to-head comparison studies with the reference product.

Biosimilars, Year One: FDA Estimates 2 Applications, 1,720 Hours Of Work

Mon, 28 May 2012 00:00:00 -0400

The agency’s expectation is that there will be a limited number of biosimilar applications, but the applicants will need as much time as traditional BLA sponsors to prepare their submissions.

Biosimilar Suffix Naming Idea Trips On Dispensing Problem

Mon, 21 May 2012 00:00:00 -0400

American Pharmacists Association tells FDA during biosimilar guidance hearing that using suffixes to create unique names will be problematic. FDA may be leaning toward the unique names, saying published literature indicates adequate safety tracking is not possible without them.

Post Biocon, Pfizer Pushes Forward On Biosimilar MABs

Mon, 21 May 2012 00:00:00 -0400

Biosimilars pioneers face a steep learning curve and multiple surprises, as shown by Pfizer’s recent and expensive backtrack on its deal with India’s Biocon. But Pfizer says the setback has reaffirmed its strategy as it pushes ahead on its own with a monoclonal antibody program, led by a biosimilar rituximab.

Pfizer’s Biosimilar Program: A MAB Dash After Biocon Deal Ends

Fri, 18 May 2012 00:00:00 -0400

Following the breakup in March of its insulin biosimilars deal with Biocon, Pfizer confirms plans to develop monoclonal antibody biosimilars on its own, and has put its first candidate, rituximab, into Phase 1 testing.

Pfizer’s Biosimilar Program: A MAB Dash After Biocon Deal Ends

Fri, 18 May 2012 00:00:00 -0400

Pfizer’s Biosimilar Program: A MAB Dash After Biocon Deal Ends

Thu, 17 May 2012 00:00:00 -0400

FDA’s Greatest Biosimilar Impact May Be Interchangeability Policy, Sandoz Says

Wed, 09 May 2012 00:00:00 -0400

As the agency and stakeholders gear up for public hearing, Sandoz argues that since Europe has not addressed interchangeability, FDA could step to the forefront by focusing on it as part of implementing the U.S. biosimilar pathway.

Daiichi Sankyo Adds To Japan's Biosimilar Fray In Two-compound Deal

Tue, 08 May 2012 00:00:00 -0400

Daiichi Sankyo is teaming with virtual startup Coherus BioSciences for etanercept and rituximab.

Pfizer/Protalix’s Elelyso Offers Gaucher Patients A Vegetarian Option

Mon, 07 May 2012 00:00:00 -0400

Gaucher disease enzyme-replacement therapy Elelyso is the first FDA-approved plant-cell based recombinant therapeutic protein, a biosimilar option that may eliminate the production-related problems Genzyme’s Cerezyme and Shire’s Vpriv face with animal cell-based processes. Pfizer is launching Elelyso at a 25% discount to Cerezyme and promising to maintain a two-year supply.

On The Trail Of Biosimilar Disclosure Scofflaws: FTC To Watch For Anti-Competitive Issues

Mon, 07 May 2012 00:00:00 -0400

As FDA prepares for another public hearing on the pathway, FTC says the rules requiring biosimilar applicants to share information with their reference product competitors could lead to anti-competitive issues and may be an ongoing concern.

[Daiichi] to sell [Coherus]’ biosimilar versions of etanercept and rituximab in Asia

Tue, 01 May 2012 00:00:00 -0400

[Daiichi Sankyo Co. Ltd.] is getting exclusive rights to develop, manufacture, and market start-up [Coherus BioSciences Inc.]’s biosimilar versions of etanercept and rituximab in certain Asian countries including Japan, South Korea, and Taiwan. Coherus retains all development and commercialization rights outside of Daiichi’s territories. Etanercept, a biosimilar form of [Amgen]/[Pfizer]’s {Enbrel}, is a recombinant protein indicated for various autoimmune diseases including psoriasis and rheumatoid arthritis. Rituximab, sold by [Genentech]/[Roche]/[Biogen Idec] as {Rituxan}/{MabThera}, is an antineoplastic agent that treats chronic lymphocytic leukemia; rheumatoid arthritis (when administered with methotrexate); and certain types of non-Hodgkin's lymphoma. Coherus, which was founded in 2010 by former Amgen, Genentech, and Immunex executives, has only just emerged from stealth mode simultaneously with the Daiichi deal. Coherus believes it can efficiently create biosimilars at lower costs through collaborations with partners that can perform certain activities--for instance, the start-up has teamed up with a global CRO to conduct clinical trials; platform companies to gain access to several technologies including cell-line development; and a top contract manufacturer. Coherus also plans to out-license marketing rights to its products; Daiichi is its first commercial partner. For now, Coherus is focusing on five initial candidates in the cancer and inflammation areas. In the past couple years, Daiichi has diversified from branded drugs and also made investments in follow-on biologics, particularly in Japan where the Ministry of Health, Labor and Welfare provided official guidelines for biosimilars in early 2010. That same year, Daiichi’s [Ranbaxy] division bought an additional 20% of [Zenotech Laboratories], which specializes in cancer and CNS biosimilars development, bringing its ownership to 67%. In addition, Ranbaxy and [Pfenex] forged an alliance in 2010 to work on an undisclosed follow-on biologic using the biotech’s Pseudomonas recombinant protein expression technology.

Reimbursement of Biosimilar and Biosimilar-similar ESAs

Mon, 30 Apr 2012 00:00:00 -0400

Affymax received FDA approval for the first new ESA in years. Now the company is trying to secure favorable reimbursement for its product, Omontys.

FDA Biosimilar Guidances Stir Innovator Worries About BLA Exclusivity, Trade Secrets

Mon, 30 Apr 2012 00:00:00 -0400

Brand pharma/biotech stakeholders say that BLA sponsors should not have to request and justify the award of 12 years of innovator exclusivity, as FDA’s draft guidance suggests. They also raise concerns about disclosure of BLA trade secrets, with Abbott asserting that approval of biosimilars that reference products licensed before March 2010 would constitute a “taking.”

Biosimilar Interchangeability: Stakeholders Want More FDA Guidance, Fewer Hurdles

Mon, 30 Apr 2012 00:00:00 -0400

The limited discussion of interchangeability in FDA’s initial biosimilar draft guidances has left some stakeholders clamoring for more details. Others say the agency’s demand for a “higher standard” of evidence to show interchangeability is misplaced and will inhibit use of the 351(k) pathway.

FDA Studies In Brief

Thu, 26 Apr 2012 00:00:00 -0400

FDA studies why patients can’t switch among bioequivalent antiepileptics, how potentially biosimilar protamine sulfates vary, which firms pose the greatest drug import/export risks, how to evaluate quality management systems and how to get more results oriented.

Biosimilar Guidance Comments Reveal Small Window Of Agreement On Foreign Data

Mon, 23 Apr 2012 00:00:00 -0400

In comments on FDA’s three biosimilar draft guidances, PhRMA and BIO seek a more limited role in biosimilar approval decisions for clinical data involving foreign reference products than does GPhA, but all the trade associations believe that the foreign product needs to be made by the same company in the same facility as the U.S.-licensed reference product.

Nippon Kayaku Submits NDA For G-CSF Biosimilar In Japan

Mon, 19 Mar 2012 00:00:00 -0400

Nippon Kayaku Co. Ltd.

Pfizer’s Diminished Expectations For Insulin Biosimilar Market Likely Scuttled Partnership With Biocon

Thu, 15 Mar 2012 00:00:00 -0400

Pfizer and India’s Biocon called off their four-product diabetes biosimilar partnership on March 12, with Biocon keeping more than $100 million realized over the life of the deal and regaining all product IP.

Pfizer’s Diminished Expectations For Insulin Biosimilar Market Likely Scuttled Partnership With Biocon

Wed, 14 Mar 2012 00:00:00 -0400

Pfizer’s Diminished Expectations For Insulin Biosimilar Market Likely Scuttled Partnership With Biocon

Tue, 13 Mar 2012 00:00:00 -0400

[Abcam] pays $155mm for monoclonal antibody producer [Epitomics]

Thu, 01 Mar 2012 00:00:00 -0500

[Abcam PLC] has acquired fellow antibody research tools company, privately held [Epitomics Inc.], for $155mm. Half of the sum will be paid in cash, with the rest in the form of approximately 14.7mm Abcam shares (based on the pre-announcement ten-day average of £3.34 ($5.29)). Epitomics, which was founded in 2002 and has operations in the US, China, and Taiwan, specializes in the commercial supply of monoclonal antibodies sourced from rabbits via the patented {RabMAb}, the only hybridoma-based technology available to produce custom rabbit monoclonals. The company says that rabbit antibodies have higher specificity and affinity and demonstrate more diverse epitope recognition and better response than mouse MAbs. Epitomics also sells reagents, in vitro diagnostics for cancer, and contract research services. Its primary customers are biotech and pharmaceutical companies as well as academia. Epitomics previously developed biosimilar antibody therapeutics for oncology and immunology, but spun off this asset in 2010 to the start-up [Apexigen]. Upon closing the deal, Epitomics is estimated to have $15mm in net cash. As of FYE December 31, 2011, the company had unaudited revenues of $24.7mm, EBIDTA of $7.6mm, profit before tax of $6.8mm, and $30mm in net assets. The Epitomics acquisition marks Abcam’s entry into the in vitro diagnostics market and builds on its core high-quality primary antibodies business, which services the life science industry. The company is also boosting its presence in other research products such as proteins, peptides, immunoassays, and kits. Last year it bought [MitoSciences], a mitochondrial research tools company that brought assay development capabilities.

Samsung and Biogen Idec Launch Biosimilar Joint Venture

Tue, 28 Feb 2012 00:00:00 -0500

Samsung Bioepis' board of trustees voted a Samsung executive to serve as CEO.

Biosimilars Trigger Analytical Frenzy as Innovators Look to Update Methods

Tue, 28 Feb 2012 00:00:00 -0500

As biosimilar developers ‘fingerprint’ molecules with state-of-the-art assays in hopes of winning reduced clinical trials or more, innovators are updating their analytical methods, hoping to alert FDA before their competitors about any issues the old methods may have missed. As the ‘totality of the evidence’ on their molecules increases exponentially, concerns are raised about the proliferation of non-critical specifications.

FDA's Projected $20 Mil. In 2013 Biosimilar User Fees Translates Into 68 More Staffers

Mon, 13 Feb 2012 00:00:00 -0500

Administration’s proposed fiscal year 2013 spending plan includes $4.5 billion for FDA, with $2 billion or 44% provided by various user fees.

FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics

Mon, 13 Feb 2012 00:00:00 -0500

The agency’s first three draft guidances on biosimilar product development describe how to characterize biosimilar and reference products and extrapolate data on one condition of use to another. FDA says interchangeability is difficult to determine now and will require a switching study.

FDA’s Biosimilar Guidances Win Praise For High Hurdles, Flexibility

Mon, 13 Feb 2012 00:00:00 -0500

Merck Bioventures and Hospira execs say the draft guidances are consistent with their approach to biosimilars development. One attorney says FDA’s broad and flexible approach will require the agency to be careful to ensure a level playing field for sponsors.

FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics

Mon, 13 Feb 2012 00:00:00 -0500

FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics

Thu, 09 Feb 2012 00:00:00 -0500

Korea’s Celltrion Prepares Remicade Biosimilar Application For KFDA

Tue, 07 Feb 2012 00:00:00 -0500

Korea’s biosimilar frontrunner Celltrion is only one step away from the actual sales of its first biosimilar as it gears up to file for KFDA approval in February for its biosimilar of Johnson & Johnson’s rheumatoid arthritis agent Remicade.

Lovenox Generics: FDA’s Split Opinion On ANDA Approval Fully Supported By Court

Tue, 07 Feb 2012 00:00:00 -0500

The decision will give FDA ammunition for future battles over biosimilar approvals as Sanofi’s suit against the agency is tossed out. The court notes there was a split within FDA over its five-pronged test for active ingredient sameness, which the judge sees as evidence that the issues were carefully weighed.

Biosimilars: Inverting the Innovator Development Model

Wed, 01 Feb 2012 00:00:00 -0500

When it comes to the new biosimilar pathway, it’s the IND—not the BLA—that matters.

Nichi-Iko And Sanofi Ink Remicade Biosimlar Deal

Thu, 26 Jan 2012 00:00:00 -0500

Nichi-Iko Pharmaceutical will collaborate with Sanofi to develop biosimilar antibody infliximab in Japan.

Biosimilars Guidance On Interferon Beta From EMA Foreshadows Possible Joint EU/U.S. Approach

Tue, 24 Jan 2012 00:00:00 -0500

EMA’s biosimilars interferon beta guideline, which says that magnetic resonance imaging of disease lesions may be enough to demonstrate similarity. More important perhaps, it’s the first guidance issued under the watch of new EMA chief Guido Rasi, who strongly supports allowing single data package for EU and U.S. biosimilar medicines.

Biosimilar, Generic and Rx User Fees Rely On Different Adjusters For Needed Appropriations

Mon, 23 Jan 2012 00:00:00 -0500

The biosimilar and generic drug user fees use different CPI measures, meaning they could increase the appropriations needed to allow user fee collection at different rates.

All the Guidance They Need: Biosimilars Business Development Doesn't Wait For FDA

Sun, 15 Jan 2012 00:00:00 -0500

Wall Street is eagerly awaiting formal guidance from FDA on the new biosimilar pathway in the US. Biotech companies large and small aren't waiting.

[Dako] to create a companion diagnostic for [Amgen]

Sun, 01 Jan 2012 00:00:00 -0500

Diagnostics company [Dako AS] has agreed to help develop a companion test for [Amgen Inc.]’s undisclosed investigational drug candidate for a rare type of cancer. Amgen’s pipeline contains numerous oncology compounds that could be part of the deal, including motesanib (first-line breast and non-small cell lung cancers) and {Vectibix} (locally advanced head and neck cancer and first-and second-line colorectal cancer; the drug is already marketed for second-line treatment of EGFR-expressing, unresectable, advanced or recurrent metastatic colorectal cancer). Just weeks ago Amgen also penned a deal with [Watson Pharmaceuticals] to develop several oncology antibody biosimilar drugs. Dako has signed several agreements for companion diagnostics for cancer treatments over the last few years, including ones with [AstraZeneca], [Bristol-Myers Squibb], and [Genentech].

PlantForm Corp.

Tue, 27 Dec 2011 00:00:00 -0500

PlantForm Corp. calls the antibodies it’s producing in tobacco plants “subsequent-entry-biologic” antibody drugs. The first marketed product it hopes to emulate is Roche’s Herceptin.

Amgen, Watson Aim For First Joint Oncology Biosimilar In 2017 To Open International Doors

Wed, 21 Dec 2011 00:00:00 -0500

The deal is a key part of both companies’ plans for aggressive international expansion because they will be able to spread fixed costs and offer robust portfolios to vastly different geographically diverse customers.

Amgen, Watson Aim To Launch First Joint Oncology Biosimilar In U.S. In 2017

Tue, 20 Dec 2011 00:00:00 -0500

The partners’ flexibility allows them, together and separately, to establish solid footholds in a still-evolving field with plenty of potential but also uncertainties.

FDA Meetings With Biosimilar Sponsors Aim To Make 351(k) Pathway OK

Tue, 20 Dec 2011 00:00:00 -0500

Short public meeting on the biosimilar user fee agreement suggests the proof will be in the scheduling.

FDA Meetings With Biosimilar Sponsors Aim To Make 351(k) Pathway OK

Fri, 16 Dec 2011 00:00:00 -0500

Short public meeting on the biosimilar user fee agreement suggests the proof will be in the scheduling.

Biosimilar User Fee Agreement Allows For Reliance On Foreign Clinical Data, FDAer Says

Thu, 15 Dec 2011 00:00:00 -0500

Agency interactions with sponsors under BsUFA are not dependent upon opening an IND. Sponsors may be able to demonstrate similarity to an FDA-licensed reference product by bridging to foreign clinical data, Associate Director for Biosimilars Leah Christl says.

Biosimilar User Fee Agreement Allows For Reliance On Foreign Clinical Data, FDAer Says

Wed, 14 Dec 2011 00:00:00 -0500

Biogen Tests Biosimilars Waters In Joint Venture With Samsung

Mon, 12 Dec 2011 00:00:00 -0500

A joint venture with Korean conglomerate Samsung will be limited to making generic versions of non-Biogen products, although Samsung separately is working on a biosimilar of rituximab.

Biosimilar User Fee Program Stresses FDA/Sponsor Meetings Early And Often

Mon, 12 Dec 2011 00:00:00 -0500

BsUFA agreement negotiated between the agency and industry provides five different types of meetings during the pre-IND and product development stage. FDA will issue a draft guidance on the different types of biosimilar meeting opportunities by 2014.

Biosimilar User Fee Agreement Includes “Financial Hold” On Development Programs For Failure To Pay

Tue, 06 Dec 2011 00:00:00 -0500

Biosimilar INDs could be placed on “financial hold” if sponsors fail to timely pay product development fees under FDA’s inaugural biosimilar user fee deal with industry.

Amgen’s Stealth Enbrel Patent May Block Biosimilars; Scenario May Apply To Other Biologics

Mon, 05 Dec 2011 00:00:00 -0500

Amgen’s patent may keep Enbrel biosimilars off the market until at least 2028. Other biosimilar sponsors could face similar submarine patents that derail their commercialization plans.

Korea’s Celltrion Initiates Clinical Trials Of Roche’s Rituxan Biosimilar

Fri, 02 Dec 2011 00:00:00 -0500

Celltrion takes a step forward in its biosimilar ambitions by commencing clinical trials of a key pipeline product.

Korea’s Celltrion Initiates Clinical Trials Of Roche’s Rituxan Biosimilar

Fri, 02 Dec 2011 00:00:00 -0500

Celltrion takes a step forward in its biosimilar ambitions by commencing clinical trials of a key pipeline product.