Faricimab

EMA approves Roche's Vabysmo prefilled syringe for nAMD, DME, and RVO, aiming to challenge Regeneron's Eylea in the ophthalmologic market. Vabysmo sales grew 324% to $2.64bn, while Eylea's sales declined 3% to $9.38bn. GlobalData forecasts Vabysmo to reach $8.78bn by 2030, with Eylea projected at $2bn.

Roche announces EU approval of Vabysmo PFS, the first bispecific antibody prefilled syringe for treating nAMD, DME, and RVO, offering a convenient alternative to vials.

Roche announces EU approval of Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for nAMD, DME, and RVO, offering a convenient alternative to vials. Vabysmo PFS is the first prefilled syringe containing a bispecific antibody for retinal conditions, co-packaged with a CE-marked needle for intravitreal injection.

The global red biotechnology market was valued at USD 405.84 billion in 2024 and is projected to reach USD 649.31 billion by 2033, growing at a CAGR of 5.36%. Key drivers include advancements in gene therapy, monoclonal antibodies, and immunotherapy, as well as increased funding for R&D. Regulatory challenges and high costs remain significant constraints.

Roche's Vabysmo included in China's NRDL for 2025-2026 in three indications, with positive interim results in PCV.

Roche Holding AG CEO Thomas Schinecker is optimistic about the company's latest Alzheimer’s drug, which has shown effectiveness in breaking up amyloid plaques. The drugmaker presented its data at the CTAD medical conference. Roche's third-quarter sales rose 9% to 15.1 billion Swiss francs, driven by key medicines. The company confirmed its forecast for high-single-digit adjusted earnings per share growth.

The Age-Related Macular Degeneration (AMD) Drugs Market is projected to reach USD 17.37 Billion by 2029, growing from USD 10.46 Billion in 2024 at a CAGR of 10.7%. Factors driving growth include an aging population, lifestyle factors, and rising incidences of AMD. Vabysmo is expected to show the highest growth due to positive feedback and efficacy. Hospitals will witness high growth as end users. Biologics will dominate the approval type segment. North America is the fastest-growing region. Key companies profiled include Regeneron Pharmaceuticals, Bayer AG, F. Hoffmann-La Roche Ltd, and Novartis AG.

Genentech's phase 3 ELEVATIM study showed Vabysmo effectively treats DME in underrepresented racial/ethnic groups, improving vision by 12.3 letters on average after 1 year, with no new safety issues.

Regeneron's Eylea sales miss estimates, UCB sees potential in Alzheimer's drug bepranemab, Madrigal's Rezdiffra sales exceed expectations, AbbVie partners with EvolveImmune for cancer drugs, Lundbeck acquires Longboard Pharmaceuticals, and PTC Therapeutics awaits FDA decision on Translarna for Duchenne muscular dystrophy.