Search Results: Uncategorized

FDA Committee Recommends Approval of Bevacizumab and Trastuzumab Biosimilars

The FDA Oncologic Drugs Advisory Committee (ODAC) unanimously supported biosimilar versions of Roche’s cancer drugs Avastin (bevacizumab) and Herceptin (trastuzumab). Amgen and Allergan’s Avastin biosimilar candidate, ABP 215, was reviewed for six of eight of Avastin’s indications. Mylan and Biocon’s Herceptin biosimilar candidate, MYL-1401O, was reviewed for all of Herceptin’s indications….

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Bioverativ Files Itc Complaint Against Csl’s Idelvion® Alongside District Court Infringement Suit

In an earlier post, we discussed the recent rise in Section 337 proceedings against pharmaceutical products and medical devices at the International Trade Commission.  Last week, Bioverativ, which markets the recombinant Factor IX product, Alprolix®, filed a Section 337 complaint against importation of CSL’s Factor IX product, Idelvion®, alongside a patent…

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Hospira Opposes Amgen’s PI Motion in Amgen v. Hospira

On July 6, 2017, Hospira filed a publically available redacted version of its brief responding to Amgen’s motion for a preliminary injunction (PI).  As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Amgen filed a revised brief in support of its PI motion.  Amgen argued that Hospira’s…

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EMA Issues Statement of Non-Compliance for Biocon’s Biosimilar Manufacturing Facility

As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, and they have filed applications for marketing authorization in the European Union for three biosimilar products: Fulphila (Pegfilgrastim), Ogivri (Trastuzumab), and Semglee (Insulin Glargine).  The French National Agency for Medicines and Health Products Safety (ANSM), on…

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Review Article Supports Interchangeability of Infliximab and CT-P13

BioSimilars Patent Dance

Last week, an article reviewing the literature comparing infliximab biosimilar CT-P13 (Celltrion) with infliximab (Janssen Biotech) for the treatment of rheumatologic diseases was published in Drug Design, Development and Therapy. Noting that many European specialists had reported having only a basic knowledge of biosimilars, the authors sought to critically analyze…

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PTAB Issues Additional Final Written Decisions Finding AbbVie's Humira Patent Unpatentable

On July 6, 2017, the PTAB issued two additional Final Written Decisions finding AbbVie’s U.S. Patent 8,889,135 (“the ‘135 patent”) unpatentable as obvious over the prior art.  The Final Written Decisions were issued in IPR2016-00408 and IPR2016-00409, both filed by Boehringer Ingelheim.  As we reported here, the ‘135 patent had previously been found unpatentable as…

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Pfizer Files Two Petitions for IPR of Genentech's Trastuzumab Patent

Pfizer has filed two petitions for IPR of U.S. Patent 8,591,897, owned by Genentech: IPR2017-01726 and IPR2017-01727.  According to the petitions, the ‘897 patent is directed to methods for treating patients with non-metastatic HER2-positive breast cancer by administering anthracycline/cyclophosphamide (AC) based chemotherapy, followed by sequential administration of a taxoid and…

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