Latest News
At Biocon Biologics in Canada, we recognize that regular, effective, balanced and timely communication is important to help us maintain our credibility as a trusted brand. In this section we provide company information related to key business developments, achievements, regulatory approvals and recognitions. We also share our brand stories and relevant content from our social media channels.
Biocon Biologics Receives Health Canada Approval for Yesintek™ and Yesintek™ I.V. (ustekinumab), a Biosimilar to Stelara®
TORONTO, Ontario, Canada and BENGALURU, Karnataka, India: October 23, 2025 Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), today announced that Health Canada has granted a Notice of Compliance (NOC) for Yesintek™ (ustekinumab injection) and Yesintek™ I.V. (ustekinumab for injection, solution for intravenous infusion), a biosimilar to Stelara® (ustekinumab injection) and Stelara® I.V. (ustekinumab for injection, solution for intravenous infusion). The approval was granted on October 17, paving the way for Canadian commercial availability in mid-October. YESINTEK and YESINTEK I.V. are indicated for the treatment of moderate to severe plaque psoriasis in adult patients and in pediatric patients (6-17 years of age), active psoriatic arthritis in adults, moderately to severely active Crohn’s disease and ulcerative colitis in adults—a range of debilitating autoimmune conditions that affect thousands of Canadians. Health Canada approval was based on a comprehensive data package, confirming that YESINTEK is highly similar to Stelara with no clinically meaningful differences in efficacy, safety and immunogenicity. YESINTEK will be available through the My Biocon Biologics™ patient support program, which provides assistance to individuals prescribed with the therapy. YESINTEK is available as a subcutaneous injection, 45 mg/0.5ml (prefilled syringe and vial) and 90 mg/ml (prefilled syringe) and YESINTEK I.V. as an intravenous solution, 130 mg/26mL (5mg/mL). Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said: “Health Canada’s approval of Yesintek™ marks a significant milestone in our mission to expand global access to high-quality biosimilars. Building on our successful U.S. launch, this approval strengthens our presence in North America
Biocon Biologics’ Yesafili® (aflibercept) Now Publicly Funded in Ontario, Canada for the Advanced Treatment of Patients with Retinal Diseases
TORONTO, Ontario, Canada and BENGALURU, Karnataka, India: September 18, 2025 Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), is pleased to announce that Yesafili® (aflibercept), a biosimilar to Eylea® (aflibercept) injection, in vial and prefilled syringe presentations, 2 mg/0.05 mL is now publicly funded on the Ontario Drug Benefit Formulary/Comparative Drug Index for the advanced treatment of patients with retinal diseases in Canada. YESAFILI was the first biosimilar to EYLEA to be approved by Health Canada. The Ontario Drug Benefit (ODB) Formulary is the official listing that determines which prescription medicines are covered under the public insurance system in Ontario, Canada’s largest province. This listing, which was effective August 29, 2025, ensures eligible patients will be covered through public funding, improving access to care. YESAFILI (aflibercept) is approved for treating neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema secondary to central or branch retinal vein occlusion (CRVO/BRVO), diabetic macular edema (DME) and myopic choroidal neovascularization (myopic CNV). Retinal conditions like wet AMD affect over 2 million Canadians1 and are a leading cause of irreversible vision loss worldwide, placing mounting pressure on patients, caregivers and healthcare systems.2 Ramy Ayad, Head of Canada at Biocon Biologics, stated: “Ontario’s public funding of Yesafili®, Canada’s first biosimilar to Eylea® and the seventh biosimilar product we have launched in the country, underscores our commitment to working with provinces to expand access to biologics and build a sustainable biosimilars environment. By providing a high-quality, affordable option, YESAFILI helps remove significant cost barriers for patients
Biocon Biologics Secures Canada Market Entry Date for YESAFILI®, a Proposed Biosimilar to EYLEA® – Biocon Biologics
Biocon Biologics Ltd (BBL), a globally integrated biosimilars company and a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), has announced the signing of a settlement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. This Agreement paves the way for the introduction of YESAFILI®, a proposed biosimilar to EYLEA® (aflibercept) Injection, into the Canadian market. Under the terms of the agreement, Biocon Biologics has secured a launch date for YESAFILI® 2 mg NDS for vials and prefilled syringes (yet to be filed), set no later than July 1, 2025. In March 2023, Health Canada had granted tentative approval for YESAFILI® 2 mg vials, subject to resolution of any patent issues. The settlement resolves multiple parallel patent infringement proceedings in the Federal Court of Canada involving six patents, and associated judicial review proceedings, under Canada’s Patented Medicines (Notice of Compliance) Regulations addressing pre-entry pharmaceutical patent litigation.
Biocon Biologics and Viatris Launch Abevmy® (bBevacizumab), Their Third Oncology Biosimilar, in Canada – Biocon Biologics
Bengaluru, India and Toronto, Canada, May 19, 2022 Biocon Biologics Ltd., a subsidiary of Biocon Ltd., and Viatris Inc. (NASDAQ: VTRS) announced today that Abevmy® (bBevacizumab) is now available in Canada. Abevmy, co-developed by Biocon Biologics and Viatris, is a biosimilar to Roche’s Avastin® (Bevacizumab) and has been approved by Health Canada across four oncology indications. Matthew Erick, Chief Commercial Officer, Advanced Markets, Biocon Biologics, said: “With the launch of Abevmy, (bBevacizumab), we are adding another world-class biosimilar to our oncology portfolio in Canada, which includes Ogivri (Trastuzumab) and Fulphila (Pegfilgrastim). Abevmy will be an important addition to our existing portfolio and will enable us to expand patient access to another affordable biologic for cancer care.” Viatris Canada Country Manager David Simpson commented: “With patients at the heart of what we do, we are proud to bring Abevmy to market to provide increased access and affordability in oncology. Abevmy is the fourth biosimilar to be offered by Viatris in Canada and our third to support patients living with cancer. Our vast experience in biosimilars has resulted in a substantial oncology portfolio which expands choices for patients across the nation.” Abevmy follows the launch of our two oncology biosimilars in Canada, Ogivri (bTrastuzumab) in 2019 – the first Trastuzumab approved in the country – and Fulphila (bPegfilgrastim), which was launched in 2020. In addition to the therapeutic area of oncology, Viatris Canada launched Hulio (bAdalimumab) in February 2021 for chronic inflammatory conditions. The Viatris AdvocateTM program is also now available for Abevmy. The program offers support and resources for patients, their caregivers and their healthcare providers. The approval of Abevmy was based on
Biocon and Mylan Launch Fulphila®, Biosimilar Pegfilgrastim, in Canada – Biocon Biologics
BENGALURU, India and HERTFORDSHIRE, England/PITTSBURGH : April 28, 2020 Biocon Ltd. (BSE code: 532523, NSE: BIOCON) and Mylan N.V.today announced the launch of Fulphila®, a biosimilar to Neulasta® (pegfilgrastim). Fulphila is approved by Health Canada to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. The approval of Fulphila was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that the product is highly similar to Neulasta and no clinically meaningful differences in terms of safety and efficacy exist. Biocon Biologics, CEO, Dr Christiane Hamacher said, “We are pleased to expand access to our high quality biosimilar pegfilgrastim to patients in Canada, after a successful launch in the US. This is the second biosimilar from our portfolio to be launched in Canada by our partner Mylan and is an endorsement of our science, development and manufacturing capabilities in the area of biologics. We are committed to serve 5 million patients through our biosimilars portfolio and cross a revenue milestone of US$1bn by FY22.” Mylan Canada Country Manager David Simpson commented, “As a global leader in the development of complex products, including biosimilar medicines, Mylan is proud to launch Fulphila in Canada. We have reached a negotiated agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) to help expand access to treatment and reduce costs for cancer patients. Fulphila is the second biosimilar to be offered by Mylan through the Mylan-Biocon Biologics partnership in Canada and the second biosimilar approved by Health Canada through this collaboration to support