1. Generics Bulletin
  2. >>Products
  3. >>Biosimilars

Biosimilars Report Bolsters IGBA’s Calls To Streamline Development Process

IPRP Biosimilars Working Group Urges Reassessment Of Comparative Efficacy Studies

 
• By Dave Wallace

The IGBA has renewed calls to streamline biosimilar development by reducing comparative clinical studies and using the same comparator product across international jurisdictions, citing the findings of a recent publication by the International Pharmaceutical Regulators Programme’s Biosimilars Working Group.

IGBA logo
The IGBA wants a more streamlined approach to biosimilar development • Source: IGBA

A fresh call to international regulators urging the streamlining of biosimilar development and registration processes has been voiced by the International Generic and Biosimilar Medicines Association, in the wake of recent recommendations from the International Pharmaceutical Regulators Programme’s Biosimilars Working Group.

In a report summarizing a workshop on increasing the efficiency of biosimilar development programs and re-evaluating the need for...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Biosimilars

Patent Settlements Are ‘Critically Necessary’ As AAM Calculates $423bn Savings Since 2013

 
• By Urtė Fultinavičiūtė

The US healthcare system saved billions by allowing early market entry for generic and biosimilar medicines through patent settlements. However, long-winded litigations with an expensive price tag and the Senate’s reintroduced pay-for-delay bill are set to make the situation even more dire.

US ‘Red Tape’ Bill Again Targets Biosimilar Interchangeability – Will It Succeed This Time?

 
• By Dave Wallace

After multiple past attempts, US legislators have once again proposed a bill that would make all biosimilars immediately interchangeable upon approval. Could a fresh political context help it to succeed this time?

Xbrane Sets Date For Latest Run At Ranibizumab In US

 
• By Dave Wallace

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Dr Reddy’s And Alvotech Team Up On Keytruda Rival

 
• By Dave Wallace

After previously partnering on denosumab, Alvotech and Dr Reddy’s have announced a further alliance to co-develop a biosimilar version of Keytruda (pembrolizumab).

More from Products

Xbrane Sets Date For Latest Run At Ranibizumab In US

 
• By Dave Wallace

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Dr Reddy’s And Alvotech Team Up On Keytruda Rival

 
• By Dave Wallace

After previously partnering on denosumab, Alvotech and Dr Reddy’s have announced a further alliance to co-develop a biosimilar version of Keytruda (pembrolizumab).

Biocon To Launch Approved Generic Liraglutide ‘Expeditiously’ In India

 
• By Urtė Fultinavičiūtė

Marking its first vertically integrated GLP-1 product in India, Biocon said the generic liraglutide was approved under CDSCO’s Rule 101, which recognizes approvals from “established and referenced serious regulatory authorities.”