Clinical trials leading up to biosimilar approval may not reveal the full safety and efficacy profile of biosimilars vs reference products, and postmarketing studies may be essential to elucidate any differences, investigators said.
The rituximab biosimilar candidate ABP 798 met primary and secondary end points for safety, efficacy, and immunogenicity in a study presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology (ASCO).
Fresenius Kabi has tapped pharmaceuticals distribution company medac to amplify sales of its pegfilgrastim biosimilar in Germany.
Daewon Pharmaceutical has launched Terrosa, a teriparatide biosimilar, on the Republic of Korea market, after signing a domestic sales agreement with Richter-Helm Biotec. The drug is intended for the treatment of osteoporosis.
A study of coverage decisions by some of the nation’s largest payers indicates biosimilars get preferred status just 14% of the time.
Fresenius Kabi’s pegfilgrastim biosimilar candidate has demonstrated a similar safety and immunogenicity profile to the reference product (Neulasta).
Taiwan-based JHL Biotech said it has initiated a phase 1 clinical trial of its denosumab biosimilar candidate for bone loss.
If it has strong intentions to develop the IL-23 agent brazikumab for commercialization, AstraZeneca did not show its hand when it acknowledged receipt of the agent from Allergan last week.
Icelandic company Alvotech said clinical trials for its adalimumab candidate have demonstrated equivalence to reference product Humira.
Celltrion is pinning its hopes on a higher-concentration formulation of adalimumab to gain elbow room among multiple competing products.

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