&w=3840&q=100)
Biocon Biologics to launch Eylea biosimilar Yesafili in Canada next month
Biocon Biologics, a subsidiary of Biocon Ltd, has received approval from Health Canada for Yesafili (aflibercept), a biosimilar to Eylea, marking the first such approval for an Eylea biosimilar in the country. The authorisation, granted via a Notice of Compliance (NOC), covers both vial and prefilled syringe formats (2 mg/0.05 mL). Yesafili is set to launch in Canada on July 4.
Shreehas Tambe, chief executive officer and managing director, Biocon Biologics, said: 'The approval of Yesafili by Health Canada—the first biosimilar to Eylea in Canada—is a proud moment for Biocon Biologics. We are excited that in July, Canada will be the first country where we will launch Yesafili, making it our 10th biosimilar to be commercialised worldwide. This milestone reflects our science-driven innovation, global commercialisation strength and continued commitment to expanding access to high-quality, affordable biologics for patients across the globe.'
Yesafili is a vascular endothelial growth factor (VEGF) inhibitor indicated for treating several retinal conditions that cause visual impairment. These include neovascular (wet) age-related macular degeneration (AMD), macular oedema resulting from central or branch retinal vein occlusion (CRVO and BRVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV).
Furthermore, the company said the approval is based on a comprehensive package of analytical, nonclinical and clinical data, confirming that Yesafili is highly similar with no clinically meaningful differences to Eylea regarding quality, safety and efficacy.
In April this year, Yesafili received approval for launch in the United States. In May 2024, the US Food and Drug Administration approved Yesafili.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Economic Times
a day ago
- Economic Times
Canada hikes wage thresholds for Temporary Foreign Worker Program
Agencies Canada has increased the wage thresholds for employers hiring under the Temporary Foreign Worker Program (TFWP), a move that will impact new Labour Market Impact Assessment (LMIA) applications submitted from June 27, 2025, as per a CIC News report. Employment and Social Development Canada (ESDC) confirmed the revision affects nearly all provinces and territories, altering how foreign nationals qualify under either the high-wage or low-wage streams of the Temporary Foreign Worker Program is used by employers when no Canadian citizen or permanent resident is available to fill a job. The program's classification between high-wage and low-wage streams is determined by comparing offered wages against the median hourly wage of the province or territory. Wage thresholds revised across provinces The updated wage benchmarks will directly influence employer eligibility for LMIAs. For example, the threshold in Ontario rose from CAD 34.07 to CAD 36.00, while British Columbia saw an increase from CAD 34.62 to CAD 36.60. The threshold in Nunavut remained unchanged at CAD 42.00. Provinces such as Quebec, Alberta, and Nova Scotia also recorded moderate must apply under the high-wage stream if they offer wages at or above the new thresholds. Otherwise, they must proceed under the low-wage stream, which faces additional limitations. Employment and Social Development Canada (ESDC) reiterated that a moratorium remains in effect for LMIA applications under the low-wage stream in areas with unemployment rates at or above 6%. This policy, active since September 26, 2024, will continue until at least July 10, federal government has also restricted low-wage LMIA approvals based on the structure of an employer's workforce. Generally, low-wage positions must not exceed 10% of the total workforce at a given location. However, specific industries like construction (NAICS 23), food manufacturing (NAICS 311), hospitals (NAICS 622), and nursing care facilities (NAICS 623) are permitted a 20% cap. Moreover, ESDC confirmed that similar restrictions now apply to select caregiving roles under the National Occupation Classification (NOC) system. This includes roles such as registered nurses (NOC 31301) and home childcare providers (NOC 44100). 'ESDC and Immigration, Refugees and Citizenship Canada (IRCC) are reviewing the effects of including these in future measures,' the statement added. Policy changes reflect government's broader reforms The changes come amid increased scrutiny over the TFWP in 2024, when reports surfaced alleging worker exploitation and wage suppression. The federal government has since implemented several reforms: shortening LMIA validity to six months, cutting employment durations under the low-wage stream, capping new foreign worker admissions, and eliminating in-country job-supported work permit options for updates reflect a broader policy shift aiming to balance the country's labour market needs with concerns about temporary resident volumes and pressure on public services. (Join our ETNRI WhatsApp channel for all the latest updates) Elevate your knowledge and leadership skills at a cost cheaper than your daily tea. The bike taxi dreams of Rapido, Uber, and Ola just got a jolt. But they're winning public favour Second only to L&T, but controversies may weaken this infra powerhouse's growth story Punit Goenka reloads Zee with Bullet and OTT focus. Can he beat mighty rivals? 3 critical hurdles in India's quest for rare earth independence HDB Financial may be cheaper than Bajaj Fin, but what about returns? Why Sebi must give up veto power over market infra institutions These large- and mid-cap stocks can give more than 23% return in 1 year, according to analysts Are short-term headwinds from China an opportunity? 8 auto stocks: Time to be contrarian? Buy, Sell or Hold: Motilal Oswal initiates coverage on Supreme Industries; UBS initiates coverage on PNB Housing
Business Standard
2 days ago
- Business Standard
Biocon's biologics arm gets Health Canada approval for aflibercept biosimilar 'Yesafili'
Biocon said that its subsidiary Biocon Biologics has received a notice of compliance (NOC) for Yesafili (aflibercept), a biosimilar to Eylea (aflibercept) injection, in vial and prefilled syringe presentations, from Health Canada. This approval paves the way for the launch of YESAFILI in Canada, scheduled for 04 July 2025. YESAFILI is the first biosimilar to EYLEA to be approved by Health Canada. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor. It is prescribed for the treatment of several eye conditions. These include neovascular (wet) age-related macular degeneration (AMD). It also treats visual impairment caused by macular edema secondary to central retinal vein vein occlusion (CRVO). Visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) is another indication. Furthermore, it is used for diabetic macular edema (DME). It also treats myopic choroidal neovascularization (myopic CNV). The approval is based on a comprehensive package of analytical, nonclinical, and clinical data, confirming that YESAFILI is highly similar with no clinically meaningful differences to EYLEA in terms of quality, safety, and efficacy. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: The approval of YESAFILI by Health Canadathe first biosimilar to EYLEA in Canadais a proud moment for Biocon Biologics. We are excited that in July, Canada will be the first country where we will launch YESAFILI, making it our 10th biosimilar to be commercialized worldwide. Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions like diabetes, cancer, and autoimmune diseases. The companys consolidated net profit surged 154.2% to Rs 344.50 crore on a 12.8% jump in net sales to Rs 4,358.10 crore in Q4 FY25 over Q4 FY24. The scrip rose 0.96% to currently trade at Rs 353.90 on the BSE.
Business Standard
2 days ago
- Business Standard
Biocon Biologics to launch Eylea biosimilar Yesafili in Canada next month
Biocon Biologics, a subsidiary of Biocon Ltd, has received approval from Health Canada for Yesafili (aflibercept), a biosimilar to Eylea, marking the first such approval for an Eylea biosimilar in the country. The authorisation, granted via a Notice of Compliance (NOC), covers both vial and prefilled syringe formats (2 mg/0.05 mL). Yesafili is set to launch in Canada on July 4. Shreehas Tambe, chief executive officer and managing director, Biocon Biologics, said: 'The approval of Yesafili by Health Canada—the first biosimilar to Eylea in Canada—is a proud moment for Biocon Biologics. We are excited that in July, Canada will be the first country where we will launch Yesafili, making it our 10th biosimilar to be commercialised worldwide. This milestone reflects our science-driven innovation, global commercialisation strength and continued commitment to expanding access to high-quality, affordable biologics for patients across the globe.' Yesafili is a vascular endothelial growth factor (VEGF) inhibitor indicated for treating several retinal conditions that cause visual impairment. These include neovascular (wet) age-related macular degeneration (AMD), macular oedema resulting from central or branch retinal vein occlusion (CRVO and BRVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV). Furthermore, the company said the approval is based on a comprehensive package of analytical, nonclinical and clinical data, confirming that Yesafili is highly similar with no clinically meaningful differences to Eylea regarding quality, safety and efficacy. In April this year, Yesafili received approval for launch in the United States. In May 2024, the US Food and Drug Administration approved Yesafili.
