Xbrane Sets Date For Latest Run At Ranibizumab In US

 
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After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Zydus Strikes Landmark $141m Agreement To Break Into Global CDMO Business

 
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Zydus Lifesciences said it would be able to leverage supply chain dynamics and a “favorable geopolitical environment” to expand its reach in the US and globally as it penned a trio of agreements to plant its flag in the global CDMO space.

Dr Reddy’s And Alvotech Team Up On Keytruda Rival

 
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After previously partnering on denosumab, Alvotech and Dr Reddy’s have announced a further alliance to co-develop a biosimilar version of Keytruda (pembrolizumab).

Formycon And Fresenius Launch Partnered Stelara Rival In Canada

 
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Several years after the initial signing of their agreement, Formycon and Fresenius Kabi announced the launch of their Stelara biosimilar Otulfi in Canada, adding another key market to their list.


Glenmark Adamant FDA Monroe Site Reinspection Could Happen ‘Any Time’

 
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A weak second half in Glenmark’s India business during the firm’s 2025 financial year took the gloss off its earnings somewhat for the year. However, Glenmark is plotting several avenues to return to growth, in both of its core business regions: India and the US.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
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Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.

‘Why Wouldn’t You Use This?’: Teva Plots $2bn LAI Schizophrenia Franchise

 
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Teva has laid out an ambitious goal for its long-acting injectable schizophrenia drugs to grow into a $2bn franchise, ahead of the planned US filing of olanzapine later this year.


Sandoz Leads Charge With First US Denosumab Launch

 
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Competition to Amgen’s Prolia and Xgeva denosumab brands has hit the US market, with Sandoz taking the lead by launching its interchangeable Jubbonti and Wyost biosimilars.

‘Obsessive’ Teva Aims For $800m Biosimilar Sales By 2027

 
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Teva says it is now in the “accelerate growth” phase of its strategic roadmap, with global biosimilar launches set to help the firm achieve its goals.

Alvotech And Advanz Add Three More In €160m EU Partnership Expansion

 
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Fresh from filing a proposed biosimilar to Xolair (omalizumab) in the UK, Alvotech and Advanz have shaken hands on a further deal to expand their partnership.

After Dasatinib Apotex Debuts US Tasigna Competition

 
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Canada’s Apotex is continuing to spearhead generic competition in the tyrosine kinase inhibitor (TKI) space for chronic myelogenous leukemia, with the launch of the first generic version of Novartis’ Tasigna (nilotinib) blockbuster.


Abiogen And mAbxience Join Forces In Italy

 
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Spanish biosimilars developer mAbxience has struck a deal with Italy’s Abiogen covering an undisclosed biosimilar for the Italian market.

Krka Looks To Kick On In India And China

 
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Krka has provided updates for its pair of joint ventures in two key Asian markets, India and China, as the Slovenian firm reported its first-quarter financial results.

Teva Brings In European Trastuzumab With Prestige BioPharma Agreement

 
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Teva will now market biosimilar Herceptin in both the US and Europe, after penning an agreement with Singaporean firm Prestige BioPharma for its Tuznue rival to the monoclonal antibody to treat HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

SteinCares Deal Leads Lupin’s Ranibizumab Into Latin America

 
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Lupin is planning to make inroads into the Latin American biosimilars market through a deal with local player SteinCares for a ranibizumab rival to Lucentis.


Hikma Gears Up To Enter US Biosimilars Market With Ustekinumab Nod

 
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Hikma is set to make its first launch into the competitive US biosimilars market after its Bio-Thera-partnered Stelara rival, Starjemza, was approved by the FDA.

Advanz Allies With Pharmathen On Long-Acting Injectable

 
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Advanz Pharma has announced details of a fresh alliance on long-acting injectables with Pharmathen.

Zydus To Continue Mirabegron Sales

 
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Zydus expects strong mirabegron sales in FY26 amid US litigation even as it builds a growth pillar in vaccines with a world-first, Gates Foundation-aided dual shigella-typhoid vaccine under development and others on the WHO prequalified list.

Sawai Reports ‘Solid Overall’ Full Year Results Despite Some Misses

 
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Continuing in its medium-term business plan and company reform, Sawai forecasts its revenue to exceed ¥200bn in the coming fiscal year.