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 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.”