• Products
  • Suppliers
  • Sourcing Requests
Post Sourcing Request Exhibition
Get alerted on the PharmaSources E-Newsletter and Pharma Sources Insight E-Compilation!
Note: You can unsubscribe from the alerts at any time.
Advertising
New Products
Gelatin, Soft Capsule Gelatin, Hard Capsule Gelatin, Pharmaceutical Gelatin-Foodmate
Neohesperidin
Advantame
Cleanroom Bench Horizontal Laminar Flow Hood Airflow Clean Bench
Pharma and Food Grade, USP/FCC Neotame Sweetener E961
Trilobatin

FDA Approves Renflexis

drugs.comApril 24, 2017

Tag: FDA , biosimilar

FDA today approved Renflexis (infliximab-abda) for multiple indications. Renflexis is administered by intravenous infusion. This is the second FDA-approved biosimilar to U.S.-licensed Remicade.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

Previous:HitGen and Pfizer partner to build and screen new DNA-Encoded Libraries

Next:Atara Bio, Merck in Clinical Combo Alliance

Related News

Everest Medicines Announces Acceptance of the New Drug Application for VELSIPITY

Everest Medicines LimitedDecember 20, 2024

Everest Medicines announced NMPA acceptance of NDA for VELSIPITY(R) (etrasimod) to treat moderately to severely active UC.

Manulife Hong Kong Partners with New Frontier Group to Enhance Cross-Border Healthcare Services

PRNewswireDecember 12, 2024

Menarini Group and MEDSIR Present the Phase III Study ADELA: A New Therapeutic Strategy for Advanced Breast Cancer

PRNewswireDecember 12, 2024

FDA Approves Renflexis | Pharmasources.com

Core8 Group and MedArmor to Pioneer Vietnam's First AI x ESG Hospital

PRNewswireDecember 12, 2024

Core8 Group, an Australian leader in high-tech and biotech innovation, has unveiled plans to develop Vietnam's first AI x ESG Hospital, marking a significant milestone in healthcare transformation.

You may like
More>>

Tacrolimus (FDA)

Tacrolimus (FDA)
Daunomycin HCL( FDA)

Daunomycin HCL( FDA)
Vitamine B12 (FDA)

Vitamine B12 (FDA)
Medroxyprogesterone Acetate(FDA)

Medroxyprogesterone Acetate(FDA)
Ramantadine( FDA)

Ramantadine( FDA)
Vecuronium Bromide(FDA)

Vecuronium Bromide(FDA)
Clindamycin Phosphate( FDA)

Clindamycin Phosphate( FDA)
Cyclosporin A (FDA)

Cyclosporin A (FDA)
Praziquantel (FDA)

Praziquantel (FDA)
Eptifibatide acetate USFDA china manufacture 99%min

Eptifibatide acetate USFDA china manufacture 99%min

Contact Us

PharmaSources@imsinoexpo.com

Tel: (+86) 400 610 1188

WhatsApp/Telegram/Wechat: +86 13621645194

About Us
About PharmaSources
Terms of Service
Privacy Policy
Intellectual Property
Media Partners
Buy
Search Products
Post Sourcing Requests
Search Suppliers
CAS Search
Sell
Member Application
Advertising
Post Products
EZSourcing
Events
CPHI China
PMEC China
Conferences
Search Events
Help
FAQ
Contact Us
Feedback
PharmaSources Customer Service