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Celltrion Wins Korea Approval For Roche Herceptin Biosimilar

 
• By Peter Chang

Celltrion gains approval for its second monoclonal antibody biosimilar following a biosimilar of Johnson & Johnson’s Remicade. The approval marks the second entry of a Herceptin biosimilar and the first based on global clinical trials, but Roche believes it is adequately protected against the competition.

SEOUL – South Korea’s biosimilar frontrunner Celltrion Inc. received approval from the Ministry of Food and Drug Safety for sales in Korea of Herzuma (trastuzumab), a biosimilar of Roche’s blockbuster Herceptin (trastuzumab). MFDS approved the compound for early and advanced HER2-positive breast cancer and for advanced stomach cancer.

The product is Celltrion’s second approved monoclonal antibody biosimilar following Remsima, a biosimilar of Johnson & Johnson’s tumor necrosis factor inhibitor Remicade (infliximab). Remsima is available in Korea and...

More from Europe

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

More from Geography

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.