Pressure on Merck re: biosimilars?
As per Google AI
Yes, several countries and companies are preparing to produce or have recently authorized alternatives to Merck's branded pembrolizumab (Keytruda), largely driven by the goal of increasing access to affordable cancer treatments as the original patent nears expiration around 2028.
Key Developments in Alternative Production:
Vietnam and Russia: In November 2025, Vietnam's Ministry of Health authorized the circulation of Pembroria, a Russian-manufactured version of pembrolizumab, for a three-year period. This drug, produced by the Russian company Limited Liability "PK-137," is set for use in hospitals, such as K Hospital in Hanoi, to provide a more cost-effective alternative.
Brazil: PlantForm, in partnership with Brazil's Bio-Manguinhos (a division of the Brazilian Ministry of Health), is developing a biosimilar of pembrolizumab for the Brazilian market, utilizing plant-based manufacturing technology.
Global Biosimilar Development: Several pharmaceutical companies are actively conducting Phase 3 trials for pembrolizumab biosimilars, with launches expected around 2028–2029. Key players include:
Samsung Bioepis (SB27): Phase 3 trials for a biosimilar, with potential for filing in 2026.
Sandoz (GME751): Developing a biosimilar with trials potentially leading to approvals around 2027-2028.
mAbxience (MB12): Conducting Phase 3 trials for a biosimilar to be in play for 2027.
Amgen (ABP-234): Developing a biosimilar for non-small cell lung cancer.
Context on Production:
While Merck is investing heavily to increase its own production capacity, including a new $1 billion facility in Delaware, the aforementioned initiatives represent efforts to introduce generic or biosimilar versions to reduce the high cost of treatment. Most of these alternatives are targeting market entry after 2028, when core patent protections in major markets like the U.S. and EU are expected to expire.
As per Google AI
Yes, several countries and companies are preparing to produce or have recently authorized alternatives to Merck's branded pembrolizumab (Keytruda), largely driven by the goal of increasing access to affordable cancer treatments as the original patent nears expiration around 2028.
Key Developments in Alternative Production:
Vietnam and Russia: In November 2025, Vietnam's Ministry of Health authorized the circulation of Pembroria, a Russian-manufactured version of pembrolizumab, for a three-year period. This drug, produced by the Russian company Limited Liability "PK-137," is set for use in hospitals, such as K Hospital in Hanoi, to provide a more cost-effective alternative.
Brazil: PlantForm, in partnership with Brazil's Bio-Manguinhos (a division of the Brazilian Ministry of Health), is developing a biosimilar of pembrolizumab for the Brazilian market, utilizing plant-based manufacturing technology.
Global Biosimilar Development: Several pharmaceutical companies are actively conducting Phase 3 trials for pembrolizumab biosimilars, with launches expected around 2028–2029. Key players include:
Samsung Bioepis (SB27): Phase 3 trials for a biosimilar, with potential for filing in 2026.
Sandoz (GME751): Developing a biosimilar with trials potentially leading to approvals around 2027-2028.
mAbxience (MB12): Conducting Phase 3 trials for a biosimilar to be in play for 2027.
Amgen (ABP-234): Developing a biosimilar for non-small cell lung cancer.
Context on Production:
While Merck is investing heavily to increase its own production capacity, including a new $1 billion facility in Delaware, the aforementioned initiatives represent efforts to introduce generic or biosimilar versions to reduce the high cost of treatment. Most of these alternatives are targeting market entry after 2028, when core patent protections in major markets like the U.S. and EU are expected to expire.
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