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An obstacle in Celltrion’s path to sell its rituximab biosimilar in Korea has been removed, with a court’s affirmation that a patent covering Genentech/Biogen’s Rituxan original for the use of chronic lymphocytic leukemia is invalid.
Sued by Herceptin sponsor Genentech for patent infringement, Samsung Bioepis has legal hurdles to navigate before it can roll out its trastuzumab biosimilar in the US, which has just become the third biosimilar of the cancer treatment greenlit by the FDA.
Belgium has introduced financial incentives to encourage doctors to prescribe anti-TNF biosimilars adalimumab and etanercept outside of hospitals.
A proposed SPC manufacturing waiver – which would allow generic and biosimilar manufacturing within Europe during the SPC period – has taken a step closer to being realized after the European Council approved a mandate for negotiations with the European Parliament. However, it remains uncertain whether key elements desired by the off-patent industry will fall into place.
Two infliximab switching studies have provided reassuring data on the safety of Celltrion’s CT-P13 infliximab biosimilar to treat IBD. While one report explores changing pediatric patients to CT-P13 from the Remicade reference drug, the other looks at reverse switching patients from the biosimilar to the originator brand.
With an eye on moving to market its broad pipeline of innovative brands, Pfizer has cut development of five early-stage biosimilar assets, in a decision that will affect 150 staff. The move is not reflective of Pfizer's overall commitment to biosimilars, the US-based company maintains.
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