Tagged as: EMA

European Commission Approves Pegfilgrastim Biosimilars

The European Commission (EC) recently approved two biosimilars to Neulasta (pegfilgrastim). First, Mundipharma announced last week that the EC granted approval for Pelmeg▼®, a product it had acquired from biosimilar development company Cinfa Biotech.  According to Mundipharma, the product is approved for the “use of Pelmeg▼® as a treatment for…

Read More

Biosimilars Update: Clinical Trials, Marketing Authorization Applications, Licenses, and Launches

Today, we’re catching up with news from around the industry. Amgen recently announced top-line results from a Phase 3 study evaluating its infliximab biosimilar candidate, ABP 710.  According to the announcement, the study, a randomized, double-blind trial of 558 patients over 22 weeks, demonstrated the non-inferiority of ABP 710 to…

Read More

Mylan Partners with Fujifilm Kyowa Kirin Biologics

Last week, Fujifilm Kyowa Kirin Biologics (FKB) and Mylan announced that they will partner with one another to commercialize in Europe FKB327, a biosimilar of adalimumab developed by FKB. As we previously reported, the European Medicines Agency (EMA) accepted FKB’s Marketing Authorization Application for review on May 18, 2017 and the companies expect to get a decision from EMA by the second half of this year. Under the agreement, FKB grants Mylan…

Read More

Ireland's Department of Health is Requesting Comments Regarding its National Biosimilars Medicines Policy

Ireland’s Department of Health (the “Department”) recently reported on its website that it is “developing a National Biosimilar Medicines Policy to promote the use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland.”  The Department is now asking the public for its views regarding the…

Read More

Guidance on Biosimilar Submission Requirements in Canada

Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission Requirements for Biosimilar Drugs (“Guidance”).  The Biologics and Genetic Therapies Directorate (BGTD) within the Health Products and Food Branch of Health Canada is the…

Read More

Brexit’s Impact on the Biosimilar Market

The United Kingdom’s referendum in favor of withdrawal from the European Union, colloquially known as “Brexit,” has already sent shockwaves through the business world, both within the UK, and abroad.  The impact of Brexit on the pharmaceutical industry has yet to be determined, but some fear that Brexit will cause…

Read More