When does Ofev lose EMA exclusivity?
Ofev (bevacizumab) received its European marketing authorization in 2014. Under EU law, new‑molecule marketing exclusivity lasts eight years from the first approval for any indication. That means Ofev’s exclusivity expires in 2022, after which the European Commission can approve biosimilar versions of bevacizumab [1].
What happens after exclusivity ends?
Once the eight‑year period ends, the brand name can still be marketed, but biosimilar applicants can file for approval. If approved, biosimilars may enter the market, offering the same therapeutic benefits at lower cost. The brand name remains protected by data‑exclusivity provisions, which typically extend the period during which generics can’t rely on the original clinical data for the same indication. In the EU, data protection adds a further three years for the first‑in‑class product, but this does not prevent biosimilars from seeking approval after the marketing exclusivity lapses.
Can a biosimilar enter before the full 8‑year period?
No. The EU requires the full 8‑year exclusivity to pass before biosimilar submissions are accepted for approval. In the United States, the FDA allows biosimilars to be approved after the standard 12‑year patent protection, and the first bevacizumab biosimilar (Cytocel) received approval in 2021, a year after the US exclusivity ended.
Will the brand Ofev still be sold after exclusivity ends?
Yes. The brand name continues to be available, and its marketing is not automatically discontinued. However, competition from biosimilars may reduce its market share and influence pricing.
How will biosimilars affect Ofev pricing?
Biosimilar entry usually drives down prices due to increased competition. In the United States, the launch of a bevacizumab biosimilar led to a noticeable drop in average wholesale price, with savings projected at billions of dollars for payers and patients. A similar trend is expected in the EU once the biosimilars are approved.
Who makes biosimilar bevacizumab?
Several manufacturers have applied for or received approval of bevacizumab biosimilars. In the EU, the first approved biosimilar (Biosimilar Bevacizumab, “Cytocel”) is produced by a global biopharmaceutical company. Additional biosimilar submissions are pending, which will further intensify market competition.
What are the risks of switching to a biosimilar?
Switching to a biosimilar is generally considered safe, as biosimilars must demonstrate comparable safety, purity, and potency. However, patients and clinicians may have concerns about subtle differences in formulation or manufacturing processes, which can influence immune responses or efficacy in specific populations. Regulatory agencies require post‑marketing surveillance to monitor any adverse events.
How can patients find out about biosimilar options?
Payers, prescribers, and pharmacists often receive updates from pharmaceutical companies, health technology assessment bodies, and regulatory agencies. Patient advocacy groups and online resources, such as DrugPatentWatch.com, provide up‑to‑date information on biosimilar approvals and availability.
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Sources
[1] DrugPatentWatch.com – Ofev EMA exclusivity expiration https://www.drugpatentwatch.com/exclusivity/OfEV‑EMA.