Earlier this month, the journal of Expert Opinion on Drug Delivery published results from a clinical study of BI 695501, an adalimumab biosimilar, using an autoinjector (AI). BI 695501 is a self-injectable adalimumab biosimilar that according to the publication has “demonstrated PK bioequivalence and similar clinical efficacy, safety, and immunogenicity with…
Below are some recent regulatory developments in the biologics space. As we previously reported, USP has been considering a revision to the naming conventions for the titles of biologics product monographs. Following comments from FDA, USP announced that it would not make any changes absent stakeholder consensus. Last month, USP…
Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Genentech’s Herceptin® (trasuzumab), Rituxan® (rituximab), and Avastin® (bevacizumab). Celltrion v. Genentech (trastuzumab) and Celltrion v. Genentech (rituximab) As we previously reported, on January 11, 2018, Celltrion and Teva filed two lawsuits against Genentech in the District…
As we previously reported, Sanofi-Aventis sued Merck Sharp & Dohme in the District of Delaware for patent infringement based on Merck’s proposed follow-on biologics of Sanofi-Aventis’s Lantus® and Lantus® SoloSTAR® ([rDNA origin] insulin glargine) prefilled cartridge products. On January 2, 2018, Merck moved for summary judgment of non-infringement on the grounds…
Last week, Evolus, Inc. announced updates to the regulatory progress of its BLA for DWP-450 (prabotulinumtoxinA), a follow-on biologic to Allergan’s Botox (onabotulinumtoxinA injection) product. Evolus reported that FDA issued an Establishment Inspection Report (“EIR”) to Daewoong Pharmaceutical Co. Ltd., Evolus’s contract manufacturer for DWP-450. According to Evolus, the EIR confirmed the…
Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Neupogen® (filgrastim) and/or Neulasta® (pegfilgrastim). Amgen v. Adello (filgrastim) As we previously reported, in March, Amgen filed a complaint for patent infringement against Adello Biologics based on its filing of an aBLA for a filgrastim biosimilar. …
Last week the Department of Health and Human Services (HHS) issued a request for comments on the Trump administration’s plan to lower drug prices. The HHS blueprint to lower drug prices includes improving competition by promoting innovation and competition for biologics. According to HHS, “FDA will issue new policies to improve availability, competitiveness, and adoption of…
Last week, Apotex Australia, an affiliate of the Canadian-based Apotex, Inc., announced a proposed merger of their Australian and New Zealand generic pharmaceutical and over-the-counter (OTC) operations with Arrow Pharmaceutical. This combined operation aims to offer pharmacists, patients and consumers a diverse range of almost 500 products, and permit the…
Earlier this week, Catalent Pharma Solutions and Valerius Biopharma AG jointly announced their collaboration on the manufacture of Valerius’ specialty biosimilar products. According to the press release, Catalent Biologics will provide cell line development and support cGMP manufacturing activities from Phase I through to commercial stages. The collaboration will additionally…
Last week, the Federal Circuit issued a decision in Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, in which the court held that Altaire had standing to appeal the PTAB’s final written decision in a post-grant review (“PGR”) of Paragon’s U.S. Patent No. 8,859,623 and reversed-in-part and vacated-in-part the PTAB’s Final Written Decision….