Shots:
Biocon, Bayer & Regeneron have signed an agreement to commercialize and distribute Yesafili, the biosimilar version of Eylea (aflibercept) Injections across Canada
Under the terms of the agreement, Biocon has set Jul 1, 2025, as the launch date for Yesafili (2mg NDS for vials and prefilled syringes). Earlier in Mar 2023, Health Canada approved…
Shots:
Samsung Bioepis entered into a collaborative agreement with Samil Pharmaceuticals to co-commercialize SB15, a biosimilar version for Eylea (aflibercept) for the treatment of wet age-related macular degeneration (wAMD) & diabetic macular edema (DME) across Korea
Earlier in Jun 2022, both companies had collaborated to jointly commercialize Amelivu, a biosimilar version of Lucentis for the…
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The approval was granted based on the results from the P-III (PULSAR) & P-II/III (PHOTON) clinical trials evaluating the safety & efficacy of Eylea 8mg vs 2mg dosed Q8W following initial monthly dosing in patients (N=1,164) with nAMD & DME. The 1EP of both the studies was non-inferior BCVA changes
Both the studies met…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients
During the month of September, Sandoz entered into a development and commercialization agreement…
Shots:
The US FDA approved 10 NDAs and 3 BLA in August 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 89 novel products in 2023
In August 2023, the major highlights drugs were Zurzuvae (zuranolone) approval for women with postpartum depression and Veopoz (pozelimab-bbfg) for children…
Shots:
The US FDA approved 5 NDAs and 5 BLA in February 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 19 novel products in 2023
In February 2023, the major highlights drugs were, Tezspire (tezepelumab) approval for severe asthma, Altuviiio for hemophilia A
PharmaShots has compiled…
Active Ingredient: Aflibercept
Strength: 2 mg (0.05 mL)
Dosage Form: Injection (intravitreal)
Mechanism of Action: VEGF-A and PlGF inhibitors
First Approval: US (18 Nov 2011), EU (27 Nov 2012)
Revenue1
EYLEA net sales represent a significant portion of the total revenues for both Regeneron and Bayer. Both companies jointly commercialize the product Regeneron records net product sales of EYLEA in…

