Biosimilar News

Pfizer starts the Phase I trial of biosimilar adalimumab

Biosimilar News — Fri, 14 Jun 2013 07:37:37 +0000

Pfizer, the big pharma giant has started investing in biosimilars as you already know.Last year, we have informed you about the initiation of rituximab biosimilar trial and they are also carrying out a trial for a biosimilar version of trastuzumab. This time, according to clinicaltrials.gov, we can see that, Pfizer has started recruiting patients for adalimuma biosimilar phase I trial. The reference medicine is Humira, which is used in several indications including rheumatoid arthritis. This healthy volunteers study will evaluate [...]

Increased focus on generics and biosimilars only way to make European health care sustainable, says EGA

Biosimilar News — Fri, 14 Jun 2013 07:17:37 +0000

Addressing delegates at the 19th EGA Annual Conference in Athens, Gudbjorg Edda Eggertsdottir stressed that generic and biosimilar medicines companies ensuring high-quality manufacturing jobs and know-how should remain in Europe; benefiting society and patients and increasing the competitiveness and innovative capacity of our strategic industry. “The EGA is ready to work with European and national authorities to make the concept of sustainable manufacturing a reality in Europe and calls upon the European Commission to cement the place of generic and [...]

EMA requests comment on final biosimilar guidance

Biosimilar News — Fri, 14 Jun 2013 07:01:24 +0000

The European Medicines Agency has released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance for a six-month public consultation. The document lays down the non-clinical and clinical requirements for marketing authorisation of a biosimilar claiming to be similar to a biological product already marketed. This guideline updates the previous guidance, which came into effect in 2006. Since then, 14 biosimilar medicines have received marketing authorisation in the European Union and the number of scientific-advice requests [...]

Celltrion files for approval of trastuzumab biosimilar (CT-P6) in Korea

Biosimilar News — Mon, 10 Jun 2013 11:49:21 +0000

On June 4th Celltrion officially announced that it has filed for Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration) approval of CT-P6 with same indications of the original product for breast cancer and metastatic gastric cancer. Upon receiving MFDS approval for CT-P6, Celltrion plans to launch its second mAb biosimilar product into the Korean pharmaceutical market. Celltrion previously filed for approval of their first biosimilar product Remsima in February 2012 and received approval in July of the same [...]

Oregon Governor signs legislation to create pathway for substitution of biologics

Biosimilar News — Mon, 10 Jun 2013 11:40:07 +0000

The Biotechnology Industry Organization (BIO) and Oregon Bioscience Association (Oregon Bio) commend Oregon Governor John Kitzhaber for signing legislation designed to address the regulatory issues related to the interchangeability of biological medicines. Governor Kitzhaber signed Oregon Senate Bill 460 on Thursday, June 6. The policies outlined in House Bill 2705 and Senate Bill 460 align with all five of BIO’s principles on biologic substitution. BIO and Oregon Bio furthermore commend the actions of the Oregon Legislative Assembly for unanimously passing these bills. While the U.S. Food and [...]

Hospira post-marketing study of biosimilar epoetin meets primary endpoints

Biosimilar News — Thu, 06 Jun 2013 07:09:51 +0000

Hospira, Inc., announced this week the results from a post-marketing study of the company’s European biosimilar epoetin, Retacrit. This prospective, observational study met the primary endpoint, as defined by hemoglobin treatment response, in the management of chemotherapy-induced anemia in adult patients with solid tumors, lymphomas and myelomas, regardless of chemotherapy cycle. Retacrit was well tolerated by patients in the study. Full results of the study, called ORHEO, were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) [...]

Biosimilars Global Congress 2013 Europe

Biosimilar News — Thu, 06 Jun 2013 06:20:14 +0000

Paradigm Global Events is organizing the Biosimilars Global Congress 2013 Europe in Brussels, Belgium on 17-19 July 2013. Why this conference? : • In depth market analysis will provide maximum knowledge to keep ahead of the latest trend in Biosimilar developments and commercial strategies. • Understanding the complexities of competing with next generation biologics and discuss the obstacles in bringing the next generation of Biologics to the market. • Examine the perspective, risk and opportunities of the evolving market [...]

Future Biotech India Summit 2013

Biosimilar News — Thu, 06 Jun 2013 06:12:37 +0000

ITP Publishing Group is organizing the Future Biotech India Summit in Hyderabad, India on 25-26 July 2013. If you attend this conference, you will be able to get news about: Unraveling the US FDA draft guidelines for biosimilar product development which will aid in Indian companies to enter developed markets Establishing winning strategies for biosimilar development after patent expiration of biologic products Analyzing the extent of product comparability with the innovator molecule that will drive the biosimilar market in India Insights into the next generation mAbs development and working around the clinical [...]

NACCME released survey results assessing medical education needs in biosimilars

Biosimilar News — Fri, 31 May 2013 07:41:31 +0000

North American for Continuing Medical Education, LLC (NACCME) announced the results of a survey of oncologists, rheumatologists, managed care professionals, pharmacists, and primary care learners. The study, conducted in April 2013, focused on awareness of and need for information on biosimilar agents, with results strongly supporting the need for comprehensive education on this topic. Over 400 health professionals participated in the survey, revealing: More than half of respondents said their understanding of the differences between biosimilars versus generics was only fair to [...]

GPhA supports the new legislation in Florida about biosimilars

Biosimilar News — Tue, 28 May 2013 11:04:24 +0000

At the beginning of this month, Florida joined several states, in refusing to enact legislation that would create barriers between patients and newer, lower-cost versions of biologic medicines known as biosimilars. The Florida legislature voted to approve a bill on biosimilars that follows current substitution practices for prescription medicines, rejecting efforts by Amgen and Genentech to limit future access to these therapies once they reach the market. “In the states, nothing is over until the gavel bangs, and the Florida [...]