Vedolizumab anvisa patent?

Vedolizumab (brand name Entyvio™) is a humanized monoclonal antibody that blocks the α4β7 integrin, thereby inhibiting the migration of gut‑homing lymphocytes into the intestinal mucosa. It is approved for moderate to severe ulcerative colitis and Crohn’s disease.

1. Patent Landscape in Brazil

The exact dates can vary slightly because the 12‑year term is calculated from the earliest filing date. In Brazil, patents expire on the 12th anniversary of the first filing, not the grant date.

2. ANVISA (Brazilian Health Regulatory Agency)

• Initial Approval: Entyvio® was approved by ANVISA in 2014 (Registration 108/2013‑D) for inflammatory bowel disease (IBD).

• Patent Exclusivity: During the period of patent protection, Roche had market exclusivity for the biologic. ANVISA’s “Exclusividade de Patente” (patent exclusivity) policy prohibits the import of generic biologics that would infringe any active patents.

• Generic Approval Process: Once all patents expire and a “patent clearance” is obtained (including any “secondary” patents, e.g., formulation, delivery devices, or combination therapies), a generic applicant can file a “License for the Production and Sale of a Biosimilar” (CDSMP – “Cadastramento de Produto Biosimilar”). The process involves:

  1. Pre‑registration: Submission of a “Technical Information for the Biosimilar” dossier.
  2. ANVISA Review: Evaluation of analytical, pre‑clinical, and clinical data showing biosimilarity.
  3. Patent Clearance: Verification that no active patents remain (or that the applicant has licenses).
  4. Market Authorization: Approval of the generic product.

• Current Status (2026): As of mid‑2026, ANVISA has not yet granted a license for a vedolizumab biosimilar, largely because some of the secondary patents (e.g., on the formulation with a specific buffer or the drug delivery device) still hold exclusivity until late 2026. Once cleared, the first biosimilar is expected to enter the market in 2027‑2028.

3. What Does This Mean for Patients and Clinicians?

4. Practical Tips for Stakeholders

• For Patients: If you’re on Entyvio® and interested in cost‑effective alternatives, talk to your gastroenterologist about the status of biosimilars. The first approved biosimilar in Brazil should appear by late 2027, offering a price advantage (typically 30‑60 % lower).
• For Prescribers: Keep an eye on ANVISA’s “Portal de Biosimilares” for updates. If you are considering prescribing a biosimilar once available, ensure it’s the same formulation and dosing schedule as Entyvio®.
• For Pharmaceutical Companies: If you plan to launch a vedolizumab biosimilar in Brazil, start the pre‑registration dossier early (2024‑2025) to align with the patent expiry window.
• For Researchers: The primary data on vedolizumab biosimilar equivalence in other markets (e.g., EU, US) can guide the design of your studies to meet ANVISA’s requirements.

5. Key Take‑away

• Patents expired in 2023‑2026 depending on the specific claim.
• ANVISA’s review process is ongoing and no generic is approved as of 2026.
• First biosimilar expected around late 2027‑2028 once patent clearance and regulatory approval are completed.

Feel free to ask if you need more granular details—such as specific patent claims, the exact timeline for a particular generic applicant, or how the SUS (public health system) plans to incorporate vedolizumab biosimilars.