Join Free For Buyer|Sign In

Professional Online Trade Platform for API, Preparation and Pharmaceutical Machinery and Equipment_EN-CPhI.cn

You are here:  Home >>  News >>  Market News >>  FDA antibody biosimilar product approvals increase in 2019

FDA antibody biosimilar product approvals increase in 2019

August 12, 2019 By europeanpharmaceuticalreview
Tag: FDA , antibody , 2019

Findings show that the US Food and Drug Administration (FDA) approval of biosimilar antibody therapeutics has increased in 2019. A total of six antibody products have been approved in the first seven months of the current year.

 antibody

The Antibody Society report that sixteen antibody biosimilar therapeutics were approved in total from March 2015 to July 2019. The numbers of these approvals each year are:

2015 – zero

2016 – two

2017 – five

2018 – three

The 2019 approvals include Trazimera (trastuzumab-qyyp) in March, Kanjinti (trastuzumab-anns) in June and Ruxience (rituximab-pvvr) in July.

The antibody biosimilar products use five reference drugs:

Trastuzumab (five biosimilars)

Adalimumab (four biosimilars)

Infliximab (three biosimilars)

Bevacizumab (two biosimilars)

Rituximab (two biosimilars)

Other biosimilar products that are awaiting approval include FYB201, a biosimilar candidate for Lucentis® (ranibizumab), produced by Formycon and Bioeq IP AG. This is expected in late 2019 and approval from the European Medicines Agency (EMA) is predicted in early 2020.

Clinical trials are being held by Samsung Bioepis Co and Sandoz, who are testing biosimilars for ranibizumab and denosumab respectively.

-----------------------------------------------------------------------
Editor's Note:

If you have any suggestion to the content, 

please email: Julia.Zhang@ubmsinoexpo.com

Readers'Comments
Add a comment
Click here to Login or to Register for free. You will be taken back to your selected item after Login/Registration.
More>> MarketNews
More>> Editors’Picks
More>> TopStories
More>> HotTags
Follow Us
CPhI Online Trade Platform: Worldwide|English|中国站
Customer Service:  86-400 610 1188 (9: 00-18: 00, Mon-Fri)
About Us| Contact Us| Terms of Services| Privacy Policy| Intellectual Property Statement| Links | Site Map
Copyright 2006-20 Shanghai Sinoexpo Informa Markets International Exhibition Co. Ltd (All Rights Reserved). ICP 05034851-53
客服
live chat