Regulatory

The Center for Biosimilars® recaps the top news for the week of April 15, 2019.
Yesterday, the European Parliament approved a proposal to allow waivers of supplementary protection certificates (SPCs) for EU generics and biosimilars by a vote of 572 to 36.
According to The International Generic and Biosimilar Medicines Association (IGBA)’s paper, despite global progress in strengthening the regulatory system for medicines, progress related to biologics and biosimilars has been less robust.
The 2-part proposal from Peter B. Bach, MD, and 3 coauthors published Monday argues that biosimilar competition is an economically inefficient way to achieve the goal of lower prices.
Last week, Health Canada approved Celltrion and Teva’s biosimilar rituximab, Truxima, for the treatment of adults with non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.
 
Russian drug manufacturer Generium Pharmaceutical, which specializes in orphan drugs, announced yesterday that it has received Russian marketing approval for its biosimilar eculizumab, referencing Soliris, the most expensive orphan drug in Russia.
Genentech, together with City of Hope, has filed a new complaint for patent infringement against Pfizer over PF-06439535, Pfizer’s proposed bevacizumab biosimilar referencing Genentech’s Avastin.
 
The FDA this week finalized a 2016 draft guidance that explains when the agency deems a Risk Evaluation and Mitigation Strategy (REMS) program to be necessary for a given drug.
The Center for Biosimilars® recaps the top news for the week of April 1, 2019.
In December 2018, the FDA announced its guidance for industry on the interpretation of the “Deemed to be a License” provision in section 7002(e) of the Biologics Price Competition and Innovation Act. The bill introduced this week would codify those guidelines, as they pertain to insulin, into law to prevent any future administrations from revoking them.

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