As we reported earlier, Amgen recently filed suit under the BPCIA against Sandoz and Lek Pharmaceuticals in the Northern District of California. Amgen alleges that Sandoz’s submission of an aBLA for its pegfilgrastim product (a biosimilar of Neulasta®) infringed two of Amgen’s patents under 35 U.S.C. § 271(e)(2)(C). Amgen also…
Today, the PTAB instituted IPR proceedings on claims 1-5 of U.S. Patent No. 8,889,135, drawn to a method of treating a rheumatoid arthritis patient with a TNFα-inhibitor. Humira®, marketed by Abbvie, is allegedly covered by the claims of the ’135 patent. The IPR petition was filed by Coherus Biosciences, Inc….
On June 14th, Rob Cerwinksi will speak at American Conference Institute’s 7th Annual Biosimilars Summit. Rob will address how to distinguish a biosimilar product from the reference product while minimizing the risk of legal claims that may arise from the promotion. Goodwin and the Big Molecule Watch team have a…
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The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009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…