Global patent settlement with Genentech secures earliest licensed launch dates for Pebrilzo® (bPertuzumab)
Biocon has entered into a global settlement and license agreement with Genentech.
By ScoutQuest · · 1 min read
- EU and UK launch window
- Q1 of CY 2027
- U.S. launch window
- Q3 of CY 2028
- Other RoW launch window
- CY 2026-2028, or earlier in certain circumstances
Biocon has entered into a global settlement and license agreement with Genentech, which it says secures the earliest licensed launch dates for Pebrilzo®, its biosimilar to the reference product Perjeta® (Pertuzumab).
The two companies executed the patent settlement agreement to resolve all pending disputes between them, including in the U.S., Canada and other jurisdictions.
Launch windows set out
- European Union and UK: Q1 of calendar year (CY) 2027
- United States: Q3 of CY 2028
- Other Rest of the World (RoW) countries: CY 2026-2028, or earlier in certain circumstances
What this agreement does
A biosimilar is generally launched only once the innovator's patent position is settled. This settlement and license agreement sets out, region by region, when the company can begin selling Pebrilzo®. These are licensed launch windows for the product, and the update describes them as the earliest such dates secured.
The update states that the other terms of the agreement are confidential.
About the product
Pebrilzo® is a biosimilar medicinal product and the active substance is Pertuzumab, a monoclonal antibody that binds with high affinity and specificity to the human epidermal growth factor receptor 2 (HER2), inhibiting the proliferation of tumour cells that overexpress HER2. Pebrilzo® is used for the treatment of HER2-positive breast cancer across multiple disease stages.
Points to note
- Product launches in all the countries and regions mentioned are subject to regulatory approval.
- All trademarks, registered or unregistered, are the property of their respective owners.
The company's statement also carries a forward-looking statement note that actual results may differ materially from those expressed or implied.
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