Celltrion Inc., of Incheon, South Korea, gained MFDS clearance of Eydenzelt (CT-P42) as a biosimilar referencing Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 30. The news comes on the heels of the U.S. FDA approving the first Eylea interchangeable biosimilars on May 20.
Avirmax Biopharma Inc. has received IND approval from the FDA to initiate a phase I/IIa trial for its gene therapy treatment targeting wet age-related macular degeneration (AMD), including polypoidal choroidal vasculopathy (PCV).
Celltrion Inc., of Incheon, South Korea, gained MFDS clearance of Eydenzelt (CT-P42) as a biosimilar referencing Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 30. The news comes on the heels of the U.S. FDA approving the first Eylea interchangeable biosimilars on May 20.
South Korea’s Hanall Biopharma Co. Ltd., of Songpa-gu, Seoul, agreed to an exclusive licensing deal with San Francisco-based Turn Biotechnologies Inc. to develop novel ophthalmic and optic therapies using the latter’s mRNA-based technology.
Merck & Co. Inc. is shelling out $1.3 billion in cash up front to acquire privately held Eyebiotech Ltd., gaining rights to the latter’s pivotal trial-ready diabetic macular edema drug and a pipeline of earlier-stage candidates targeting vision loss. An additional $1.7 billion could follow in development, regulatory and commercial milestones, raising the deal total to $3 billion.
Shares of Redwood City, Calif.-based Rezolute Inc., and Korean parent company Handok Inc., rose May 22 on positive results of a phase II proof-of-concept study for its investigative oral diabetic macular edema (DME) drug, RZ-402. RZ-402 is an oral small-molecule plasma kallikrein inhibitor designed to block vascular leakage and inflammation for treating chronic DME.
Shares of Redwood City, Calif.-based Rezolute Inc., and Korean parent company Handok Inc., rose May 22 on positive results of a phase II proof-of-concept study for its investigative oral diabetic macular edema (DME) drug, RZ-402. RZ-402 is an oral small-molecule plasma kallikrein inhibitor designed to block vascular leakage and inflammation for treating chronic DME.
In lieu of pending guidance, the U.S. FDA’s approval May 20 of Biocon Biologics Ltd.’s Yesafili and Samsung Bioepis Co. Ltd.’s Opuviz as interchangeable biosimilars to Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) provides further insight into how the agency is approaching the market exclusivity the Biologics Price Competition and Innovation Act awards to the first approved interchangeable for any given biologic.
Théa Open Innovation, a subsidiary of France’s Laboratoires Théa SAS, returned rights to South Korea’s Curacle Co. Ltd.’s CU-06, an oral diabetic macular edema drug candidate. Curacle posted positive top-line phase IIa data of CU-06 just three months prior.
The U.S. FDA approved the country’s first two interchangeable biosimilars, or copy products, of Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 20, to treat four eye-related conditions. The FDA granted the approvals to U.S.- and India-based Johnson & Johnson Services Inc./Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf; M-710) and South Korea’s Samsung Bioepis Co. Ltd.’s Opuviz (aflibercept-yszy; SB-15).
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