- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Sanofi Insulin Biosimilar Gets CHMP Nod
The Committee for Medicinal Products for Human Use (CHMP) has given its recommendation for the marketing authorization of Insulin aspart Sanofi.
In Europe, the Committee for Medicinal Products for Human Use (CHMP) has recommended that marketing authorization be granted for a biosimilar insulin aspart developed by Sanofi and intended for the treatment of diabetes mellitus.
A final decision from the European Commission is pending.
CHMP said the product would be marketed as a solution for injection (100 units/mL). The active substance is insulin aspart, a fast-acting insulin analogue. In the body, this is absorbed more rapidly than human insulin and can therefore act faster.
The replacement insulin acts similarly to naturally produced insulin. It facilitates uptake of glucose into skeletal muscle and fat tissue and inhibits glucose output from the liver.
The biosimilar’s reference product is NovoRapid, which was authorised in the European Union on September 7, 1999. Data show that Insulin aspart Sanofi, the product’s brand name, has comparable quality, safety, and efficacy to NovoRapid, CHMP said.
Health Canada Approves First Omalizumab Biosimilar
December 16th 2024Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.
