- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Bausch + Lomb Secures Commercialization Deal for Ranibizumab
Bausch + Lomb has secured the rights to commercialize a ranibizumab biosimilar in the United States and Canada.
Eye health business Bausch + Lomb said it has entered into an agreement to commercialize in the United States and Canada a ranibizumab biosimilar candidate (Xlucane) currently under development.
The deal is with STADA Arzneimittel AG, of Bad Vilbel, Germany, and its development partner Xbrane, of Solna, Sweden. Xbrane announced last month that it hopes to complete clinical trial enrollment for the age-related macular degeneration agent despite the limitations imposed by coronavirus disease 2019 (COVID-19) issues. Bausch + Lomb is headquartered in Laval, Canada.
The biosimilar references Lucentis, Novartis’ blockbuster drug, which loses its patent exclusivity in the United States this year and in Europe in 2022.
Seeking All Indications
The partners in the biosimilar deal aim to obtain all currently approved indications for Lucentis. In the United States, the agent is approved for wet age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema.
STADA and Xbrane will be jointly responsible for finalizing development of the biosimilar, and Xbrane will be the commercial supplier. Bausch + Lomb will handle the sales, marketing, and other commercialization efforts in both the United States and Canada, assuming regulatory approval is obtained.
“We believe that, once approved, this biosimilar ranibizumab candidate will be an excellent addition to our comprehensive eye health portfolio and further deliver on our commitment of continuing to expand and improve upon our ophthalmic portfolio for our customers and their patients,” said Yolande Barnard, vice president and general manage of US Pharmaceuticals for Bausch + Lomb, in a statement.
Company officials said they believe the biosimilar candidate has strong commercial potential in the North American marketplace. Indeed, Lucentis netted global sales of $2.1 billion in 2019.
COVID-19 has forced modifications in clinical trials to accommodate for patients’ inability to get to clinics. The danger of COVID-19 infections has also forced curtailment of some trial activities. However, Xbrane in April reported that it is on track toward approval of Xlucane ahead of the European expiration of Lucentis’ patent in 2022.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD
November 9th 2024A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.
