Yesterday, Amgen filed suit in an action for patent infringement arising under the Biologics Price Competition and Innovation Act of 2009 (“the BPCIA”), following Sandoz’s submission of an abbreviated Biologics License Application through subsection (k) pathway to license a pegfilgrastim product. The patents at issue, U.S. Patent Nos. 8,940,878 and…
Remsima, a biosimilar of Remicade (infliximab), was granted a marketing authorization throughout the European Union in 2013. Last week, Merck reported a 30% drop in Remicade first-quarter sales due to “the accelerating impact of biosimilar competition in the company’s marketing territories in Europe.” This will likely be the trend as…
Samsung Bioepis – the joint venture between Samsung and Biogen Idec – has started a phase III clinical trial for a biosimilar version of Roche’s cancer drug Avastin (bevacizumab). Bevacizumab slows the growth of new blood vessels in tumors and is used to treat various cancers. The clinical trial is…
In a recent hearing held in Amgen v. Hospira, the parties offered arguments on some novel issues relating to litigation under the BPCIA, particularly: Whether a reference product sponsor (“RPS”) can compel a biosimilar applicant to produce manufacturing information that may be relevant to other patents it holds, but is…
The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009 (“BPCI Act”). Section 7002(e) addresses the circumstances under which an application filed under section 505 of…
IPR2016-01018 (Coherus BioSciences Inc.) (U.S. Patent No. 9,114,166) Petitioner: Coherus BioSciences Inc. Patent: U.S. Patent No. 9,114,166 Title: Formulation of human antibodies for treating TNF-α associated disorders Related Product: HUMIRA® Patent Owner: AbbVie Biotechnology Ltd.
A recent court ruling and a new publication on guidelines for biosimilars in India may offer further guidance on what biosimilar and biologic stakeholders can expect from Indian regulatory authorities. In late March, India’s Central Drugs Standard Control Organization (CDSCO) published Proposed Revised Guidelines on Similar Biologics (2016), offering guidance…
In a recent biosimilars-themed issue of The Report, the New York Intellectual Property Law Association (NYIPLA) published our article on some of the potential product liability issues that biosimilar manufacturers may have to consider in the coming years, as more biosimilars hit the U.S. market. Click here to read a…
Today, the Wall Street Journal published an article by Jonathan D. Rockoff that takes an in-depth look at the actual and expected pricing of biosimilars in the U.S. For those with WSJ subscriptions, it is well worth a read: https://www.wsj.com/articles/knockoffs-of-biotech-drugs-bring-paltry-savings-1462458209.
Biocon recently announced that its global phase III clinical development program for biosimilar insulin glargine “has crossed key interim milestones,” putting Biocon “on track for regulatory filings in US and EU in FY 17.” Biocon received regulatory approval in Japan for its biosimilar insulin glargine this past March after completion…