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Strategy

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Yaral Continues Build With ‘Unique’ Levothyroxine Formulation

After launching at the end of 2022, IBSA’s dedicated US authorized generics and complex generics unit, Yaral Pharma, has brought on board another of its parent company’s products.

Deals Companies

Zydus Marks Biosimilar Entry Into Mexico With Bevacizumab Approval

Marketed as Bhava, Zydus’ bevacizumab rival to Roche’s Avastin begins the firm’s biosimilar journey in the Latin American country.

Biosimilars Approvals

Endo En Route To NYSE With Common Stock Exchange Expected Later In 2024

Endo continues to stride its financial revival path, with the latest plans to list common stock on the NYSE. Also, the firm has just launched a generic tiopronin rival to Travere Therapeutics' Thiola.

Financing Strategy

Gedeon Richter Is Latest To File European Denosumab

Gedeon Richter has revealed that its European filing for a denosumab biosimilar rival to Prolia/Xgeva has been accepted for review by the EMA.

Biosimilars Europe

Krka Enjoys 9% Pharma Sales Growth At The Half-Way Stage

Krka insisted that its margins were “stable and high,” as the Slovenian firm reported another solid quarter.

Sales & Earnings Strategy

J&J Confirms EU Stelara Biosimilars Are Imminent

One of the largest biologic opportunities for inflammatory bowel disorders, Johnson & Johnson’s Stelara, will open up to biosimilar competition in a matter of days, the originator has confirmed.

Biosimilars Commercial

Xbrane Inching Closer To Cimzia Biosimilar Trials With Batch Production

Sweden’s Xbrane Biopharma has delivered updates for two of its more long-term projects, including a proposed biosimilar to Bristol Myers Squibb’s Opdivo for which it is actively seeking a partner.

Biosimilars Manufacturing

Hyloris Replaces Leadership After Continued Transaction Woes

Marking a further development in the story of Hyloris’ in-licensing deal with QliniQ, the company’s board has announced significant leadership and organizational changes to address potential concerns.

BioPharmaceutical Belgium

Fresenius Follows US Denosumab Filing With EU Acceptance

Fresenius Kabi’s denosumab biosimilar filing has been accepted by the European Medicines Agency, coming hot on the heels of a US submission.

Biosimilars Europe

ANI Acquires Alimera Sciences To Bolster Ophthalmology Portfolio

ANI has acquired Alimera Sciences in a move to expand its rare disease business, highlighting its increasing drift from generics.

United States BioPharmaceutical

Cipla’s Verma Succeeds Kabi US Veteran Ducker As CEO

Guided by the firm’s ‘Vision 2026’ strategy, Fresenius Kabi has tapped Cipla executive Arunesh Verma to lead Fresenius Kabi USA, as former head John Ducker retires after 35 years.

Executive Changes Leadership

Celltrion’s Xolair Biosimilar Reaches UK, Following Key US Filing

Celltrion has ticked off another major regulator as it continues to lead the pack of global developers for biosimilar Xolair.

Biosimilars Approvals

Olainfarm Becomes Olpha And Sets Out European Strategy

Latvia’s Olainfarm has rebranded itself as Olpha, setting out its ambitions to become a top 10 pharmaceutical company in Europe and achieve turnover of “at least €1bn over the next ten years”.

Strategy Europe

Xbrane Working Towards Q2 2025 US Ranibizumab Approval

Xbrane plans to refile its proposed biosimilar to Lucentis by the end of 2024, after the recent disappointment of a US FDA complete response letter. However, the goal requires its manufacturing partners to successfully execute remediation plans.

Biosimilars Strategy

Rosemont Delivers On US Expansion Plans By Snapping Up Sabal

UK liquids specialist Rosemont Pharmaceuticals has delivered on promises to expand into the US market by striking a deal to acquire Georgia-based distributor Sabal Therapeutics.

Deals M & A

Taiwan’s Tanvex Welcomes US Filgrastim Approval – After String Of CRLs

Tanvex Biopharma submitted an application for biosimilar filgrastim as far back as 2018. Now, after multiple setbacks, the firm has celebrated becoming a commercial-stage company in the US.

Approvals Biosimilars
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