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The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009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: http://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…
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab). We also reported on a series of letters concerning Janssen’s request for an expedited trial in view of a possible Celltrion launch in October of 2016. In a letter filed with the court yesterday, Janssen…
In a recent meeting, the FDA proposed modifications to the application review process for possible implementation into the Biosimilar User Fee Act (BsUFA). These modifications included establishing a review model similar to “the Program” initiated under the Prescription Drug User Fee Act (PDUFA). Highlights include a mid-cycle communication, a late-cycle…
IPR2016-00912 (Swiss Pharma Int’l AG) (U.S. Pat. No. 8,815,236) Petitioner: Swiss Pharma Int’l AG Patent: U.S. Patent No. 8,815,236 Patent Title: Method of Treating Multiple Sclerosis and Crohn’s Disease Patent Assignee: Biogen Idec MA, Inc. IPR2016-00915 (Swiss Pharma Int’l AG) (U.S. Pat. No. 8,349,321) Petitioner: Swiss Pharma Int’l AG Patent:…