China Beckons: Sun Joins Indian Firms Priming For Larger Presence

Evolving regulations and emerging opportunities appear to have put China firmly on the radar of several frontline Indian firms. Sun Pharma is the latest to join those seeking a larger play in the Asian market.

China and India flags
INDIAN FIRMS ARE KEEN ON A LARGER PRESENCE IN CHINA

More Indian companies appear to be lining up to vie for a share of the Chinese market amid evolving regulations there that encourage innovation and speed up drug approvals, but also place an equal emphasis on quality and reining in costs.

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Organon Looks To Tap Tocilizumab Potential Following Biogen Acquisition

 
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Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.

Who’s Hired? Alvotech Appoints Strategy And Quality Chiefs

 
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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.

Richter Confirms European Tocilizumab Filing

Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.

Accord’s Denosumab Biosimilars Get Thumbs-Up From EMA

 
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Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.

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Organon Looks To Tap Tocilizumab Potential Following Biogen Acquisition

 
• By 

Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.

Another One Bites The Dust: FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 

The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?

EMA Validates Henlius’ Pertuzumab Biosimilar Application

 
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The EMA has accepted for review Henlius’ Perjeta biosimilar, which is to be commercialized by the Chinese company’s global partner Organon in the EU.