The Indian Pharmaceutical Alliance’s recent Global Innovation Summit 2021 saw regulatory and industry bodies call for policy intervention to provide support and incentives for innovation and R&D in the Indian pharmaceutical sector. Inaugurated by the Indian prime minister Narendra Modi, the summit saw Modi invite “everyone to ideate in India, innovate in India and make in India and make for the world.”

Current EU policy discourages the domestic manufacturing of essential medicines, say Medicines for Europe and the European Fine Chemicals Group. The associations have called for “immediate, robust and ambitious” policy change to drive manufacturing back home.

Discussions are ongoing at Health Canada on the feasibility of adopting the UK model of easing clinical study requirements for biosimilars, said director general Celia Lourenco at a recent event. Meanwhile, the US FDA’s stance is unchanged for now.

A new formulation of biosimilar Humira is now available in Japan, alongside three other presentations that join biosimilar products launched by partners Viatris and Fujifilm Kyowa Kirin Biologics at the start of this year.

The US Association for Accessible Medicines has panned the Biden administration’s Build Back Better Act, which it says threatens patient access to affordable drugs in its current form.

Pharmac has confirmed proposals to fund Amgen’s Amgevita adalimumab biosimilar rather than the Humira reference brand from next year.

Samsung Bioepis’ etanercept biosimilar, freely available in Europe, will not be sold in the US until patent expiry in 2029 following action by a US district court.

The WHO and Medicines Patent Pool have announced “the first transparent, global, non-exclusive license for a COVID-19 technology” after striking a deal for a COVID-19 serological antibody technology with the Spanish National Research Council through the WHO’s COVID-19 Technology Access Pool.

An agreement allowing the production and distribution of the US firm’s new protease inhibitor in 95 countries has been welcomed by the Medicines Patent Pool. But some medicines access advocates are not so sure it necessarily represents a good deal for lower-income countries.

Two generics saw their average UK trade prices almost double in October for very different reasons, according to the latest pricing information from market researcher WaveData.

The Biosimilars Forum, in partnership with the Pacific Research Institute, has released a report that shows state-by-state cost savings for the US if biosimilars were able to capture a market share of 75%. Meanwhile, the Association for Accessible Medicines has also released its complete 2021 US Generic And Biosimilar Medicines Savings Report, discouraging reducing incentives for patent challenges and early generic entry.

Amgen’s recent study on biosimilars trends has outlined the importance of US policy in the success of the biosimilars marketplace, insisting on the importance of increased competition and effective reimbursement and education policies. But with interests in innovative biologics as well as biosimilars, the company has also emphasized that pro-biosimilars policies must not stifle innovation and compromise free competition.