Sandoz (SWX: SDZ), the generic and biosimilar drug maker set to separate from Novartis (NYSE: NVS) next month, has received a positive review from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar. The biosimilar is intended for use in treating HER2-positive breast cancer and metastatic gastric cancers, indications for which Roche’s (SWX: RO) original medicine, Herceptin, is also approved in the region.
CHMP’s Decision Based on Comprehensive Trial Data
The CHMP’s positive opinion was informed by early- and late-stage trial data that demonstrated the biosimilar’s pharmacokinetics, efficacy, safety, and immunogenicity were comparable to those of Roche’s Herceptin. This confirmation of similarity is a critical milestone in the approval process for biosimilar drugs.
Sandoz’s Strategic Licensing Agreement
In 2019, Sandoz secured commercialization rights for the drug from Taiwan’s EirGenix, bolstering its portfolio of biosimilar offerings. This strategic move positions Sandoz to expand its presence in the biosimilar market, particularly as it prepares for its split from Novartis.
Implications for Cancer Treatment in Europe
The positive CHMP review is a significant step towards providing European patients with an additional treatment option for HER2-positive cancers. If approved, Sandoz’s trastuzumab biosimilar could offer a more cost-effective alternative to Herceptin, potentially improving access to treatment for patients across the region.-Fineline Info & Tech
