Despite meeting the FDA’s requirements, Boehringer’s higher-concentration formulation of its Cyltezo rival to Humira has yet to receive the status, putting it at odds in a landscape that now has further options with the designation – including Alvotech that still enjoys exclusivity for its own interchangeable 100mg/ml adalimumab.

With just 14% of active pharmaceutical ingredients estimated to be made in the US and China’s overall dominance in the space, a new study points to the pressing need for the US to address bottlenecks in the supply chain and proposes a string of approaches to partner with India in its de-risking efforts.

Amgen has revealed a program for a biosimilar rival to Keytruda, as it reported Q1 results that saw its biosimilars business grow by more than a tenth.

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits.

Celltrion unveils its agreement with the PBM Express Scripts that will place its Zymfentra subcutaneous infliximab on its preferred formulary after alluding to the deal in an earlier notice. 

Teva and Alvotech have confirmed deductions that it is their recently-approved 100mg/ml adalimumab biosimilar that will be used by Cigna’s Evernorth as part of a recently announced private-label deal involving Evernorth’s Quallent Pharmaceuticals.

Sandoz has secured a launch date for its newly-approved US denosumab biosimilars, settling patent litigation with Prolia/Xgeva originator Amgen.

Hikma will look to guarantee US generic competition to the powerful opioid brand Nucynta, albeit in the form of an authorized generic, as questions swirl over the appetite of at least one ANDA filer to compete on an equal footing, per the terms of a patent-litigation settlement deal.

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits.

US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.

IntelGenx has once again been frustrated in its attempts to challenge Collegium’s powerful opioid Belbuca in the US, amid ongoing litigation over the brand’s three US patents that run until December 2032. Meanwhile, Teva’s desire to push on with its own January 2027 launch has been called into question.

Bora Pharmaceuticals has completed its takeover of Upsher-Smith from Sawai, with the acquisition opening up new US opportunities for the Taiwanese company including providing the firm with its first US manufacturing sites.

The Chinese biotech reported increased growth in its revenue fuelled by its portfolio of biologic drugs and biosimilars, with further plans for approvals around the world.

Pfizer has reported US oncology biosimilars sales that were down by 47% in the first quarter of 2024, as pricing pressures took their toll.

Amgen has revealed a program for a biosimilar rival to Keytruda, as it reported Q1 results that saw its biosimilars business grow by more than a tenth.

Formycon has shared its results for 2023, reporting revenue growth and exceeding projections for its working capital, as the company prepares for approvals in the coming year. 

Generics Bulletin reports on some of the most noteworthy and important appointments affecting the global generics and biosimilar industries.

A flurry of top level recruitments made headlines in the past weeks, with the likes of Hikma, Lupin, and Viatris announcing new hires while focusing on their targets for the year.

Lupin has appointed a pair of executives to handle technical operations and information technology. At the same time, Mallinckrodt has promoted its head of brands to the firm’s executive committee and Australia’s GBMA association has made major changes to its board.

Sandoz has appointed a new CFO as it embarks on its first full year as an independent company. Meanwhile, Alvotech has named a new head of quality and Euroapi has selected a fresh CEO.