Lupin's Glumetza Settlement Costs But Spiriva Offers Hope

Talks On For Revlimid Settlement

Lupin’s Q2 was a tale of three generics settlements – on Glumetza, which is still a commercial win despite the quarter-billion dollar outgo so far, on Spiriva, which will likely lead to happy tidings next fiscal year, and on Revlimid, on which the company has yet to make up its mind.

Happy And Sad Masks
Settlements Have Varying Consequences For Lupin's Performance • Source: Alamy

Lupin Limited’s recent settlements give investors as much reason to cheer as to be concerned. A $253.2m provision for a settlement related to antitrust class actions filed in the Northern District of California regarding Glumetza (metformin) led the company to report a fiscal second quarter loss of INR14.7bn ($196.4m).

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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.

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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

 
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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.

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.