Bausch + Lomb Secures Commercialization Deal for Ranibizumab

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.