centerforbiosimilars16d
Bevacizumab Biosimilars Show Similar Efficacy, Safety in NSCLC
Patients with non-small cell lung cancer (NSCLC) taking bevacizumab biosimilars demonstrated equivalent therapeutic efficacy and similar safety profiles to those taking the originator product, Avastin ...
STAT17d
J&J sues Samsung over a contract breach for a Stelara biosimilar
As biosimilar versions of a big-selling Johnson & Johnson medicine reach the U.S. market, the health care giant accused one manufacturer of striking a “surreptitious” deal that could arguably ...
Business Standard18d
Biocon Biologics launches biosimilar alternative to Stelara in the US
The launch marks a significant move, as YESINTEK is among the first biosimilar alternatives to Stelara (ustekinumab) to enter the US market. YESINTEK is approved for Crohn’s disease, ulcerative ...
The Hindu22d
Biosimilars and the need for a policy prescription
To understand the class of drugs known as biosimilars, it is first necessary to understand the class of drugs described as biologics. Traditionally, biologics were derived through natural ...
WebMD22d
FDA OKs First Fast-Acting Insulin Biosimilar for Diabetes
Feb. 20, 2025 -- The FDA has approved a new fast-acting insulin biosimilar to help manage blood sugar in people with diabetes, including children and adults. The product, called Merilog ...
healthday23d
FDA Approves First Rapid-Acting Insulin Biosimilar for Patients With Diabetes
WEDNESDAY, Feb. 19, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric ...
The National Law Review24d
Personal Jurisdiction Considerations for International Biosimilars Companies
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation ...
Interesting Engineering24d
FDA approves first-ever rapid-acting insulin biosimilar for diabetes treatment
The U.S. Food and Drug Administration (FDA) has approved Merilog, a biosimilar to the widely used insulin product Novolog (insulin aspart), to enhance glycemic control in adults and children with ...
Benzinga.com24d
FDA Approves Sanofi's Merilog As First Rapid-Acting Insulin Biosimilar Product For Diabetes
Merilog is available in a 3 mL prefilled pen and a 10 mL vial, joining two long-acting insulin biosimilars approved by the FDA in 2021. Merilog, a rapid-acting human insulin analog, is the first ...
Medscape25d
FDA Okays New Rapid-Acting Biosimilar Insulin for Diabetes
The US Food and Drug Administration (FDA) has approved Sanofi’s Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), for treating adults and children with diabetes.
The American Journal of Managed Care25d
Denosumab Biosimilars Approved With Interchangeability to Address Osteoporosis, Fracture Risk
Ospomyv and Xbryk, biosimilars to Prolia and Xgeva, received FDA approval for osteoporosis and bone loss treatment. Clinical studies confirmed equivalent efficacy, safety, and pharmacokinetics ...