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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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Regeneron Monitoring Eylea Biosimilar Closely Following Innovative Setbacks

 
• By Dean Rudge

Regeneron says it is closely watching Amgen’s Pavblu 2mg aflibercept biosimilar, which is gaining traction via financial incentives to physicians as “the only differentiator” to its Eylea reference brand. Meanwhile, Regeneron is aiming to boost Eylea HD uptake amid regulatory setbacks.

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

 
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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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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

 
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Lupin Concedes To Wakix IP With 2030 Launch Date Agreement

 
• By Dean Rudge

Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.