Biocon Biologics gets Health Canada approval for Yesafili aflibercept biosimilar

How does Health Canada’s approval of Yesafili position Biocon Biologics in the Canadian ophthalmology market?

Biocon Biologics Limited, a fully integrated biosimilars subsidiary of Biocon Limited (NSE: BIOCON, BSE: 532523), received regulatory approval from Health Canada on June 26, 2025, for Yesafili (aflibercept), a biosimilar to the blockbuster retinal drug Eylea®. The company confirmed that the first global commercial launch of Yesafili will take place in Canada on July 4, 2025. This milestone represents Biocon Biologics’ tenth biosimilar to reach market and its first biosimilar approval for ophthalmology in North America.

This regulatory clearance, issued as a Notice of Compliance (NOC), covers both vial and prefilled syringe presentations of Yesafili (2 mg/0.05 mL), and comes after a comprehensive review of analytical, nonclinical, and clinical data. Yesafili will become the first Eylea biosimilar available in the Canadian market, marking a strategic foothold for Biocon Biologics in the high-value ophthalmology segment.

What therapeutic areas does Yesafili target and how does it compare with originator Eylea?

Yesafili is indicated for the treatment of five serious retinal diseases, including neovascular (wet) age-related macular degeneration (AMD), macular edema secondary to central or branch retinal vein occlusion (CRVO and BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV). The reference product Eylea, developed by Regeneron and marketed globally through Bayer, has generated billions in annual sales, particularly in North America and Europe.

The Canadian approval is based on data showing no clinically meaningful differences between Yesafili and Eylea in terms of pharmacokinetics, safety, efficacy, and immunogenicity. The Phase 3 INSIGHT study, which compared the two products in patients with DME, met its primary endpoints and formed the core of the regulatory package.

What is the commercial strategy behind Biocon Biologics’ launch of Yesafili in Canada?

The Canadian launch on July 4, 2025, is strategically timed to precede other key market entries, especially in the United States, where regulatory approval timelines for biosimilars in ophthalmology remain uncertain due to evolving interchangeability guidelines and patent litigation risks. By entering Canada first, Biocon Biologics gains early access to a regulated market that values price accessibility and encourages biosimilar adoption through centralized healthcare systems.

Ramy Ayad, Head of Canada at Biocon Biologics, emphasized the company’s commitment to broadening access to high-quality therapies. He noted that Canadian ophthalmologists and patients now have an affordable biosimilar option for managing retinal disorders, a market previously dominated solely by originator biologics.

How significant is this approval in Biocon Biologics’ global biosimilars roadmap?

This approval cements Biocon Biologics’ global positioning in the competitive biosimilars market, where it already serves more than 5.8 million patients across 120+ countries. With a pipeline of 20 biosimilar assets spanning oncology, immunology, bone health, and ophthalmology, the Indian biosimilars leader is aggressively expanding into specialty and chronic care segments.

The addition of Yesafili follows previous approvals and launches in Europe, the United States, and Japan for biosimilars to trastuzumab, pegfilgrastim, insulin glargine, and bevacizumab. Industry observers view this milestone as validation of the company’s end-to-end biosimilar development model—from lab to global market.

According to institutional investors, Biocon Biologics’ ability to achieve a first-to-market position in Canada for an Eylea biosimilar enhances its credibility and could support better reimbursement and formulary inclusion decisions. Furthermore, the successful regulatory navigation in Canada may signal smoother entries in Australia, the UK, and potentially Latin America.

What does the Canadian biosimilar approval landscape look like for ophthalmology products in 2025?

Canada’s biosimilar policy environment has steadily evolved to favor substitution and switching in therapeutic areas like oncology and endocrinology. Ophthalmology, however, has only recently seen biosimilar entries. Health Canada has prioritized data transparency, post-market surveillance, and physician education to support uptake.

Yesafili’s approval is significant not only because it is the first Eylea biosimilar approved in the country, but also because it could influence future biosimilar pathways for similar VEGF inhibitors like Lucentis (ranibizumab) or even longer-acting aflibercept derivatives currently in trial.

Analysts believe that biosimilar penetration in Canada could cross 60% in certain categories by 2027, driven by hospital procurement incentives and public payer support, both of which will benefit Biocon Biologics in upcoming tenders.

How is Biocon Biologics managing safety and risk communication for Yesafili?

Biocon Biologics has included detailed safety and usage guidance for Yesafili in its product monograph, aligning with Health Canada’s expectations for high-risk ophthalmic biologics. The biosimilar carries warnings for endophthalmitis, retinal detachment, and elevated intraocular pressure post-injection—risks shared with its reference product.

Patients are advised not to drive immediately after administration due to potential temporary visual disturbances. Hypersensitivity and inflammation-related contraindications are also listed, with post-marketing surveillance and adverse reaction reporting systems in place.

Healthcare providers and patients can report adverse events via Biocon Biologics’ Canadian helpline, which reflects a commitment to pharmacovigilance in line with global best practices.

How did Biocon Limited’s stock react to the Health Canada approval and what is the investor sentiment?

As of market close on June 27, 2025, Biocon Limited’s shares (NSE: BIOCON) traded at ₹354.25, up ₹3.75 or 1.07% from the previous session. Trading volumes reached 45.98 lakh shares, with a traded value of ₹162.62 crore. The stock’s 52-week high remains at ₹404.70, while the low stands at ₹291.00. At a price-to-earnings ratio of 34.86, investors appeared to cautiously price in the regulatory milestone.

Institutional sentiment has been positive but measured, with analysts viewing the Canadian approval as a critical early entry into ophthalmic biosimilars rather than a guaranteed margin expansion event. The free float market capitalization of ₹17,717 crore and the 57% delivery rate suggest medium-term investor conviction remains intact.

Given that the biosimilar market for aflibercept in Canada could generate revenues exceeding CAD 100 million annually by 2026, Biocon Biologics’ positioning as the first mover could translate into meaningful revenue contribution—especially if the product is adopted in provincial formularies and public hospital networks.

What comes next for Biocon Biologics’ global biosimilar strategy after Yesafili?

The launch of Yesafili on July 4, 2025, will likely serve as a bellwether for Biocon Biologics’ future ophthalmology ambitions, with filings expected in Australia and parts of Europe. A U.S. FDA submission for Yesafili has not yet been confirmed publicly, but industry speculation points to possible regulatory activity later in FY26.

Meanwhile, the broader pipeline continues to develop, with oncology and autoimmune biosimilars likely to see additional launches in the U.S. and Europe over the next 12–18 months. Biocon Biologics’ integration with Viatris biosimilar assets, completed in 2023, has also enhanced its global supply chain, commercial footprint, and regulatory leverage.

If Yesafili succeeds in gaining rapid market access and formulary inclusion in Canada, it may accelerate payor and physician acceptance in other tightly regulated markets. The launch will also help Biocon build a real-world evidence base, crucial for cross-border regulatory submissions.