Amgen/Allergan & Sandoz Receive Positive CHMP Opinions - Big Molecule Watch

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 Kanjinti® for approval for the treatment of the same three types of cancer as Herceptin® is approved for in the EU, including HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.  In its press release, Amgen stated that the Marketing Authorization Application for Kanjinti® was supported by “analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data,” and that its “Phase 3 comparative efficacy, safety and immunogenicity study was conducted in adult female patients with HER2-positive early breast cancer.”

Second, the CHMP adopted a positive opinion for marketing authorization of Zessly®, Sandoz’s proposed biosimilar to Remicade® (infliximab).  The CHMP opinion recommends Zessly® for the treatment of all indications of Remicade®, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.  In its press release, Sandoz stated that the CHMP’s opinion was based on a “comprehensive data package that is expected to confirm the biosimilarity of [Zessly®] to the reference medicine with analytical, preclinical and clinical data matching across quality, efficacy and safety,” and that its “clinical Phase III confirmatory study in rheumatoid arthritis (REFLECTIONS B537-02) met its primary endpoint, demonstrating equivalent efficacy of [Zessly®] to the reference medicine as measured by the American College of Rheumatology 20 (ACR20) response at Week 14.”

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