Tagged as: biosimilars

Biocon Biosimilars Facility Receives EU GMP Certification

Last week Biocon announced that it has received EU GMP certification for its biosimilars facility in Bangalore, after an inspection by European agencies this past March. Biocon’s Bangalore biosimilar facilities were also inspected earlier this year by the FDA, and last month Biocon announced the FDA issued an Establishment Inspection Report stating “that the inspection stands…

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Biosimilars Update: Clinical Trials, Marketing Authorization Applications, Licenses, and Launches

Today, we’re catching up with news from around the industry. Amgen recently announced top-line results from a Phase 3 study evaluating its infliximab biosimilar candidate, ABP 710.  According to the announcement, the study, a randomized, double-blind trial of 558 patients over 22 weeks, demonstrated the non-inferiority of ABP 710 to…

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FDA Withdraws Draft Guidance Regarding Statistical Approaches to Evaluate Analytical Similarity of Biosimilars

As we previously reported, in September 2017 FDA issued draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity that “describes the type[s] of information a sponsor of a proposed biosimilar product should obtain” to support a showing of analytical similarity to a licensed reference product biologic.  Today, FDA withdrew this draft guidance….

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Litigation Updates on Pegfilgrastim and Dupilumab

Pegfilgrastim litigation  We had previously covered Judge Stark’s grant of Coherus’s motion to dismiss Amgen’s complaint alleging infringement of the ‘707 patent in Amgen v. Coherus. Today, Judge Stark entered judgment against Amgen and dismissed the case. In the Amgen v. Mylan litigation earlier covered here, Mylan recently filed a…

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Amgen/Allergan & Sandoz Receive Positive CHMP Opinions

Last week the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended two biosimilar medicines for approval. First, the CHMP adopted a positive opinion for the marketing authorization of Kanjinti® (ABP 980), Amgen and Allergan’s proposed biosimilar to Herceptin® (trastuzumab).  The CHMP opinion recommends…

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