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Humira biosimilars set the stage for long-awaited 2023 US launches

Pharmaceutical Technology

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.

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The Brazilian pharma market: Key information and what may change

Pharmaceutical Technology

Instead, the focus remains on its domestic industry, particularly around biosimilars, while reducing reliance on imports and branded pharmaceuticals. While Brazil remains a high-growth market, investment in innovative pharmaceuticals is still limited. </p> By Tanner Pharma Group.

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2021 market access prospects for Italy

pharmaphorum

A push for biosimilars. 2021 will see simplified requirements for biosimilars being implemented. Companies can let AIFA know about biosimilars coming to market giving 30 days notice from the end of the originator patent. Lower paybacks possible. The Italian industry makes regular paybacks when spending ceilings are breached.

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OPQ’s 2023 Annual Report: an Upbeat Review of CDER’s Quality Efforts

FDA Law Blog: Biosimilars

It also noted that last year, FDA hosted a two-day public workshop and published a white paper on the regulatory framework for Artificial Intelligence in drug manufacturing, in addition to other efforts. Like many of us, OPQ seems intent on trying to keep up with how technology can/will impact pharmaceutical quality.

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Inflationary storm clouds will continue to buffet global pharma industry in 2023

Pharmaceutical Technology

However, low-cost generic and biosimilar manufacturers are likely to be particularly exposed to these economic pressures. By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

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Inflationary storm clouds will continue to buffet global pharma industry in 2023

Pharmaceutical Technology

However, low-cost generic and biosimilar manufacturers are likely to be particularly exposed to these economic pressures. By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

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Does the Drug Shortage White Paper Fall Short?

FDA Law Blog: Biosimilars

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.