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Starting off with MSD as an anchor partner, Aurobindo plans to eventually spar with the likes of WuXi and Lonza while building scale for its biologics CDMO business. Meanwhile, EMA approval for a greenfield project in China and an US FDA nod for Ryzneuta, licensed from Yifan’s Evive Biotech, signal a boost.
Italy’s Olon has opened its new R&D hub in Milan, shortly after announcing plans to expand a key manufacturing facility in India.
Five years after striking a biosimilars alliance with Iceland’s Alvotech, Turkish firm Abdi İbrahim – which boasts the country’s “largest biotech pharmaceutical manufacturing facility” – has shaken hands with Spanish developer mAbxience for technology transfer of an undisclosed oncology biosimilar.
Newly separated Sandoz has provided a trio of updates, foremost for its manufacturing and research ambitions for both biosimilars and antibiotics.
Strides expects to meet an earlier forecast $250m in FY24 US revenues via new product launches and sees peak revenues of $300m from CDMO partners for GLP-1 products. Meanwhile, it has sold a deactivated Singapore facility at a net loss, ending up with an overall loss of $18m in the fiscal second quarter.
Offering the latest details on Teva’s biosimilars strategy, CEO Richard Francis spoke about how the firm is looking to bring Alvotech’s FDA filings to the finish line as well as hinting at future biosimilars partnership deals. At the same time, he acknowledged a “bumpy” US market with a degree of uncertainty that has led the firm to allocate capital accordingly.
Teva has announced that R. Ananthanarayanan – known as Ananth – is to rejoin the company as CEO of its active pharmaceutical ingredients business after taking leading roles at Cipla and Strides in recent years. Meanwhile, Strides has disclosed a change of chief operating officer coming next year, while Civica Rx has named a manager for its sterile injectables operations.
Pharmascience CEO Martin Arès had suggested to Generics Bulletin that material investment was coming as the company looked to grow in its native Canada and shore up the local supply chain.
US FDA commissioner takes aim at supplier confidentiality in remarks at ISPE annual meeting. But while greater transparency would help avert individual shortages, better economics for generic drugs are needed to solve the problem, he said.
Third-party screening of US-marketed drug products is worse than pointless if done with subpar test methods, agency tells PDA/FDA meeting. Meanwhile, release-testing with such methods has been triggering warning letters.
Amid war in Israel, local generics industry giant Teva has indicated that it sees no “meaningful impact” on its business from the conflict, while highlighting that it is prioritizing the importance of its employees and patients.
Alvotech has announced that, “as expected”, its US filing for its AVT04 ustekinumab candidate has resulted in a complete response letter from the FDA over manufacturing facility deficiencies, following similar knockbacks for its adalimumab biosimilar. However, the firm anticipates an inspection and a new goal date for the proposed Stelara rival long before its planned February 2025 launch date.
Biocon has announced receipt of another CRL from the FDA relating to its insulin aspart biosimilar application, after the agency failed to schedule a reinspection of the firm’s Malaysia facility ahead of the latest goal date.
Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”
Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.
Glenmark Pharmaceuticals has divested its API arm to the Nirma group for over $681m, a move that will deleverage the drug maker’s balance sheet as it seeks to evolve into an “innovative/brand led organization.”
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