Tagged as: Biosimilars News

FDA Withdraws Draft Guidance Regarding Statistical Approaches to Evaluate Analytical Similarity of Biosimilars

As we previously reported, in September 2017 FDA issued draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity that “describes the type[s] of information a sponsor of a proposed biosimilar product should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  Today, FDA withdrew this draft guidance….

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Vermont and Connecticut Enact Interchangeable Biosimilar Substitution Bills

Last month we reported that Vermont, Connecticut, New Hampshire, and Alaska were in the process of considering biosimilar substitution bills.  Vermont and Connecticut recently enacted their respective bills. On May 30, Vermont Governor Phil Scott signed bill S.92 into law as Act No. 193.  The Act directs pharmacists to dispense…

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Lupin and Nichi-Iko Collaborate to Market Etanercept Biosimilar in Japan

As we reported last month, YL Biologics (a joint venture between Lupin’s subsidiary Kyowa and Yoshindo) recently submitted a New Drug Application (NDA) for Marketing Authorization of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for YLB113, a proposed biosimilar of Enbrel® (etanercept). Yesterday, Lupin and Nichi-Iko Pharmaceutical announced that they…

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Biosimilar Regulatory Submission Updates: Europe, U.S., Japan, Canada

Several biopharmaceutical developers recently announced significant regulatory submission activity in connection with biosimilar products in their pipelines.  In addition to yesterday’s news about the U.S. FDA’s approval of Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb) biosimilar product, below are some highlights: On June 1, the Committee for Medicinal Products for Human Use…

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Q1 2018 Earnings Roundup: Biosimilars Update

Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls.  Below are some highlights: On April 17, Johnson & Johnson (J&J) reported a 22.5% year-over-year (YOY) decline in U.S. sales of Remicade® (infliximab), which it attributed “to increased discounts/rebates,…

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Global Biosimilar Development Updates

Over the past week, biopharmaceutical developers from around the world provided updates on the development and availability of a number of biosimilar products and candidates.  Below are some highlights. On May 2, Mundipharma, a global network of independent associated companies, announced that the trastuzumab biosimilar Herzuma® is now available in…

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