Several biosimilar news items are of note this week, including an official move by our northern neighbor to streamline its biosimilar clinical trial requirements, a new collaboration between biosimilar makers on a Keytruda biosimilar, and a new FDA approval broadening the pediatric indications for one ustekinumab biosimilar product.
Health Canada’s Draft Guidance: Phase 3 Trials for Biosimilars not Generally Needed
Health Canada seems to be jumping on the bandwagon to streamline biosimilar development: On June 10, it issued a new draft guidance specifying that it would no longer require phase 3 trials for biosimilar approval. This move follows closely with the stated intention of the FDA and pronouncements from the European Medicines Agency.
The new draft guidance states, “The clinical studies required to support the authorization of a biosimilar are generally limited to a comparative pharmacokinetic trial conducted to demonstrate pharmacokinetic equivalence between the biosimilar and the CRBD. The study is also expected to collect data on safety and immunogenicity. Pharmacodynamic endpoints should be included, if feasible. Clinical efficacy and safety studies are typically not required for a biosimilar candidate to a CRBD with well characterized safety, efficacy, and immunogenicity profiles when the biosimilar can be compared and extensively characterized by commonly used analytical techniques and biological assays.”
In their proposal, Health Canada would reserve the right to require comparative clinical trials in certain circumstances; however, it seems that the global push towards streamlining biosimilar development continues to promise lower costs and faster timelines in the commercialization process.
Both Partners to Make and Market Their Pembrolizumab Biosimilar
Earlier this month, Alvotech and Dr Reddy’s Laboratories announced an agreement to collaborate on the manufacture and commercialization of a biosimilar candidate to pembrolizumab (reference product name, Keytruda). This agreement is a bit unusual in that the partners are both responsible for manufacturing and marketing the biosimilar once approved globally. According to their press release, Alvotech and Dr. Reddy’s will both have the right to commercialize the product globally. Currently, neither company markets (by themselves) a biosimilar in the US.
“We are very pleased to enter into this collaboration for pembrolizumab with Dr. Reddy’s. This agreement demonstrates Alvotech’s ability to leverage its dedicated R&D and manufacturing platform for biosimilars, accelerating the expansion of our pipeline by pursuing growing global markets. It further enables us to increase the availability of cost-effective, critical biologic medications to patients world-wide,” said Róbert Wessman, chairman and CEO of Alvotech. At last count, at least six manufacturers have publicly disclosed their intention to the pembrolizumab biosimilar sweepstakes when its main patent expires in 2028. Merck’s US revenues in 2023 from Keytruda were estimated to be $15 billion, and they grew globally by 18% in 2024. Keytruda is the number 1 selling drug by sales revenue, but should be a target for Medicare Fair Pricing negotiations in 2026 for implementation in 2028.
Steqeyma Gets Broader Pediatric Indication Approval
Celltrion gained FDA approval for an additional pediatric indication for its ustekinumab biosimilar Steqeyma. The approval expanded the product’s indications for the treatment of plaque psoriasis or active psoriatic arthritis in patients 6 to 17 years of age who weigh less than 60 kg. The dose to be used is a 45 mg/0.5 mL solution in a single-dose vial.
