Eye on Pharma: Omalizumab Results; Korean Insulin Launch; Quebec to Cover Byooviz

Kashiv Biosciences announced positive phase 1 results for its omalizumab biosimilar; Dongkook Pharmaceutical shared the launch of an insulin glargine biosimilar (Glargia); and Quebec, a province in Canada, said it’s adding a ranibizumab biosimilar (Byooviz) to its reimbursement list.

Phase 1 Omalizumab Results

Kashiv Biosciences has shared positive phase 1 clinical trial results for its omalizumab biosimilar (ADL018) referencing Xolair. Omalizumab is an anti-inflammatory used in patients with asthma and chronic idiopathic urticaria.

The phase 1, randomized, double-blind, comparative pharmacokinetic study included healthy participants who were prescribed either the biosimilar, the US-licensed reference product, or the EU-approved reference product via subcutaneous injection.

According to IQVIA, global and US annual sales for Xolair for 2022 were about $4.0 billion and $2.8 billion, respectively.

For all comparisons of primary end points, the 90% CIs of the geometric least squares means ratio were fully contained within the predefined equivalence margin of 0.80-1.25. The secondary objectives, safety profiles, and immunogenicity were also comparable among the 3 treatment groups.

“We are proud to announce positive phase 1 results for our third biosimilar candidate, omalizumab. This is a significant step for Kashiv towards achieving its mission of developing high-quality biosimilar products that are widely accessible and improve patients’ lives. We are looking forward to initiating dosing in the global phase 3 study soon in chronic spontaneous urticaria…patients. In parallel, we are actively seeking commercial partners globally to maximize the potential of this drug," said Sandeep Gupta, PhD, CEO of Kashiv.

Korean Launch of Insulin Glargine Biosimilar

Dongkook Pharmaceutical launched its insulin glargine biosimilar product, Glargia, according to a report from Korea Biomedical Review. The biosimilar comes in a prefilled pen and is administered once daily.

The product was developed by India-based Biocon Biologics, which has partnered with Dongkook. Dongkook is responsible for all domestic sales and marketing of Glargia in the Republic of Korea.

“We are focusing on the diabetes market as the core of new growth engines in the specialty drug market. With this agreement, we have gained differentiated competitiveness from other companies,” commented an official from Dongkook.

Quebec Reimburses Byooviz

Quebec has become the first province to reimburse Byooviz, a ranibizumab biosimilar referencing Lucentis. Ranibizumab products are vascular endothelial growth factor inhibitors (anti-VEGF) used to treat ophthalmic conditions, including age-related macular degeneration, macular edema, and diabetic retinopathy.

The province made the decision following a recommendation from the Institut national d'excellence en santé et en services sociaux in December 2022 and the successful completion in May 2023 of the pan-Canadian Pharmaceutical Alliance negotiation process for Byooviz.

“We are pleased that Byooviz has been recognized for the important value an additional anti-VEGF treatment brings to patients, physicians, and the health care system as a whole…. We are proud to provide a high quality, cost-effective treatment option for retinal vascular disorders, and look forward to continuing to work with the other provinces to provide greater public formulary access to Byooviz across the country,” said Eric Tse, general manager at Biogen Canada.

Quebec is 1 of 10 Canadian jurisdictions that have a biosimilar switching policy, where the public health plan for the region selects certain biosimilars to cover instead of the originators, requiring new-starts to begin therapy with a biosimilar and patients taking the originator to switch to a preferred biosimilar. The policy began in May 2021.