The Center for Biosimilars Staff

April 16, 2018

The FDA has finalized its guidance on the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research special protocol assessments (SPA). SPA is a process in which product sponsors may ask to meet with FDA to reach an agreement on the design and size of clinical trials and clinical or animal studies to determine whether they adequately address the scientific and regulatory requirements to support eventual marketing approval.

April 15, 2018

As nations around the world seek to reap the rewards of biosimilar savings, some countries, including Colombia, are updating their regulatory processes to better facilitate the introduction of biosimilars. A paper, recently published in the Generics and Biosimilars Initiative Journal, outlines the new landscape for biosimilar products in Colombia.

April 12, 2018

In ongoing litigation over Celltrion and Pfizer’s infliximab biosimilar, Inflectra, a Massachusetts district court has granted Celltrion’s motion for leave to file a motion for summary judgment of non-infringement.

April 09, 2018

Sanofi’s list prices for Admelog are approximately 15% lower than the originator Humalog’s prices.

April 07, 2018

Forty percent of respondents had skipped a medical test or treatment to save on costs, and 32% had skipped filling a prescription (or took less medication than prescribed) because of costs.

April 04, 2018

Data suggest that intravitreal bevacizumab increases the risk of thromboembolism, and some studies have raised the possibility of a link between bevacizumab and myocardial infarction (MI), while other studies did not find such a relationship.

April 04, 2018

Yesterday, the European Medicines Agency (EMA) opened a public consultation period concerning the European Union’s template for Good Manufacturing Practice (GMP) noncompliance statements. The EMA says that its GMP Inspectors Working Group is considering which actions will be required after an inspection concludes that a manufacturing site does not comply with GMP, especially in cases in which a statement of noncompliance could lead to a shortage of critical medicines.

April 03, 2018

In the rule, CMS said that it would lower the maximum co-pay amount for low-income subsidy (LIS) beneficiaries for biosimilar and interchangeable biosimilars to match the lower co-pay amount required for generic and preferred multiple-source drugs.

April 02, 2018

Last week, Senator Claire McCaskill, D-Missouri, together with the minority staff of the Senate Homeland Security and Government Affairs Committee (HSGAC), released a report on prescription drug price increases that affect the 20 products most commonly prescribed to seniors.

April 01, 2018

In Pfenex’s fourth-quarter 2017 investor call, Evert Schimmelpennink, CEO, president, secretary, and director, hinted that Pfenex may be ready to resume work on 2 biosimilar candidates whose programs had been on hiatus.