Strategy

EMA Greenlights Give Eylea And Stelara Biosimilars Momentum Across Europe

 
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The EMA’s Committee for Medicinal Products for Human Use has issued positive opinions for multiple aflibercept and ustekinumab biosimilars, intensifying competition for Eylea and Stelara respectively in Europe. Meanwhile, a Biocon subsidiary also received a nod for a Neulasta biosimilar.

Celltrion Reinforces Commitment To UK Biosimilars Market With New HQ

 
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Celltrion has reinforced its commitment to the UK by opening a new central operations hub in Uxbridge, while acknowledging that “major questions over the attractiveness of the market” need to be addressed to encourage development and ensure a sustainable environment for UK biosimilars.

Tevogen Will House Generics Unit In Much-Expanded New Headquarters

 
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Tevogen is looking to accelerate its growth with a major expansion of its headquarters in Warren, New Jersey, more than doubling its footprint to centralize research and development, regulatory, and corporate functions. The new facility will support the company’s evolving initiatives.

Endo Offloads Paladin As Shareholders Approve Mallinckrodt Merger

 
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As it prepares to complete its $6.7bn merger with Mallinckrodt, Endo has divested its International Pharmaceuticals business – consisting primarily of Canadian specialty firm Paladin Pharma – to Knight Therapeutics.


Beyond ‘Vanilla’ Generics: How Lupin Is Evolving To Stay Ahead Of The UK Competition

 
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As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.

Big Top-Level Shifts At Sun: Ganorkar Is MD, Ex-Takeda Exec To Helm US Business

 

Sun’s founder hands top job to company longtimer Kirti Ganorkar as the firm implements a “structured and forward-looking” succession plan, while Richard Ascroft will lead the Indian drugmaker’s North America business.

‘I Saw An Unpolished Diamond’: Iconovo CEO Wäborg On Breaking Even In 2027 And Beyond

 
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In an exclusive interview, Iconovo CEO Johan Wäborg outlines the company’s strategy to become a leader in dry powder inhalation by focusing on platform development, reformulated therapies, and B2B licensing, with a plan to break even by 2027.

Lupin Looks To Expand In China With Respiratory Alliance

 
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Lupin is planning to expand its footprint in China through a deal for a tiotropium dry powder inhaler with local player Sino Universal Pharmaceuticals.


Welch Heads Up Par Ahead Of Planned Spin-Off After Endo-Mallinckrodt Merger

 
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As Endo and Mallinckrodt continue to work towards consummating the merger they announced earlier this year, the pair have revealed further organizational details of their combined generics and sterile injectables business, which is set to be spun off after the merger is complete.

Replacements Named As Eder Leaves Stada And Medicines For Europe

 
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Stephan Eder has left Stada and stepped down as president of Medicines for Europe, with the company announcing plans for his replacement and the association naming Polpharma CEO Markus Sieger as the association’s new interim president.

Regeneron Monitoring Eylea Biosimilar Closely Following Innovative Setbacks

 
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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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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.


Corapharm Deal Offers South-East Europe Opportunity For mAbxience

 
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Hot on the heels of a recent alliance in Italy, biosimilars developer mAbxience has struck another deal – this time partnering with Corapharm in south-east Europe.

Big In Japan: Samsung Bioepis Looks To Increase Presence With Nipro Partnership

 
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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.

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).

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.