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FDA To Update Quality Metrics Guidance

 
• By Derrick Gingery

It's the only addition to the agency's 2016 agenda.

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Drug manufacturers could receive more information on FDA's intentions for collecting quality data in the coming months.

The only addition in FDA's Aug. 8 guidance agenda update for calendar year 2016 was a revised draft...

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More from Biosimilars

Stelara Biosimilar Sees Stada’s Specialty Sales Start Strong In Q1

 
• By Dave Wallace

Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.

Formycon Snatches First Brazilian Approval For Lucentis Biosimilar

 
• By Urtė Fultinavičiūtė

Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.

Corapharm Deal Offers South-East Europe Opportunity For mAbxience

 
• By Dave Wallace

Hot on the heels of a recent alliance in Italy, biosimilars developer mAbxience has struck another deal – this time partnering with Corapharm in south-east Europe.

Big In Japan: Samsung Bioepis Looks To Increase Presence With Nipro Partnership

 
• By Dean Rudge

Ahead of being spun out of its parent company Samsung Biologics later this year, Samsung Bioepis has struck an agreement to bolster its presence in another Asian market and one of the largest global pharma markets.

More from Products

Big In Japan: Samsung Bioepis Looks To Increase Presence With Nipro Partnership

 
• By Dean Rudge

Ahead of being spun out of its parent company Samsung Biologics later this year, Samsung Bioepis has struck an agreement to bolster its presence in another Asian market and one of the largest global pharma markets.

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?