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Aurobindo’s Pediatric AIDS Combo Generic Approved; Eugia Restructuring Back On Cards

Anticipates Having Six To Seven Biosimilars In Regulated Markets By 2028

 
• By Vibha Ravi

A US FDA tentative approval for Aurobindo’s dolutegravir combination generic for children should increase access under the PEPFAR program and aid sales. On a Q1 earnings call, renewed efforts to restructure Eugia, biosimilar launch plans and fallouts of oral drug shortages and damage to Pfizer’s US injectables warehouse were discussed.

Growth Strategy
Aurobindo Has Multiple Growth Strategies Up Its Sleeves • Source: Shutterstock

Aurobindo Pharma Limited is set to expand its presence in the antiretroviral (ARV) segment and improve access to AIDS treatments post tentative approval from the US Food and Drug Administration (FDA) for the first generic dispersible tablet formulation of a fixed dose combination of abacavir, lamivudine and dolutegravir.

Manufacturing the fixed dose combination (FDC) at a facility in India ensures an economical cost for the drug which combines 60mg abacavir, 30mg lamivudine and 5mg dolutegravir and is intended for use by HIV positive children under

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Tetris Deal Falls Into Place For UK’s Aspire

 
• By Dave Wallace

Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.

Apotex Extends Formosa Ophthalmic Alliance Into Mexico

 
• By Dave Wallace

Apotex has expanded an alliance formed with Formosa in August for its novel clobetasol propionate ophthalmic treatment, adding Mexican rights to its existing deal for the Canadian market.

Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
• By Dean Rudge

Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

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