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Policy and Regulation

Regulation Explore this Topic

Set Alert for Regulation

Indian Regulatory And Industry Bodies Call For Open Dialog With Policymakers

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.”

Generic Drugs Biosimilars

EU Must Stop Offshoring Of Essential Medicines, Say Trade Groups

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.

Manufacturing Policy

Health Canada Ponders UK Model On Easing Biosimilar Study Requirements

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.

Regulation Biosimilars
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Pricing Strategies; Reimbursement Explore this Topic

Set Alert for Pricing Strategies and Reimbursement

Mochida And Ayumi Launch Unique Humira Biosimilar Formulation In Japan

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.

Launches Reimbursement

AAM Speaks Out Against Build Back Better Bill

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.

Policy Legislation

New Zealand Confirms Amgevita Biosimilar Listing With Small Delay

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

Biosimilars Reimbursement
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Intellectual Property Explore this Topic

Set Alert for Intellectual Property

Samsung Bioepis Also Faces 2029 Wait For US Etanercept Biosimilar

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.

Biosimilars Intellectual Property

MPP And WHO Announce COVID Technology License Via C-TAP

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.

Intellectual Property Deals

Pfizer And MPP Sign Deal For Generics Of COVID-19 Candidate Paxlovid

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.

Coronavirus COVID-19 Intellectual Property
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Market Intelligence Explore this Topic

Set Alert for Market Intelligence

Differing Dynamics Demonstrated In UK As Duo Double In October

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.

Market Intelligence Generic Drugs

Biosimilars Forum Says 75% Market Share Could Save US Billions

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.

Biosimilars Policy

Amgen Urges Balance In US Biosimilars Policy

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.

Biosimilars Policy
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