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What’s Next? Five Things To Look Out For In August

Coherus’ Ranibizumab Date And Key Biocon Biosimilar Inspections Feature

 
• By Dean Rudge

A busy August brings patent expiries, biosimilar target action dates and the potential for a major change to biosimilar prescribing guidelines in Germany.

What's Next Image
August looks set to be another busy month • Source: Citeline

Biocon could be set to achieve long-awaited US Food and Drug Administration approvals for the company and partner Viatris’ proposed biosimilars to Avastin (bevacizumab) and NovoLog (insulin aspart) in due course, with the Indian biotech awaiting key FDA site inspections in August to get the products over regulatory line.

Both products were recently named by Viatris as anticipated new product launches for 2022 which did not currently hold FDA...

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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

 
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Corapharm Deal Offers South-East Europe Opportunity For mAbxience

 
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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.

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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?