First biosimilar of dornase alfa inhalation solution for CF approved in Russia, companies announce

19 September 2019 - A biosimilar of dornase alfa inhalation solution, with the same therapeutic activity as Pulmozyme, its reference ...

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Draft Pelosi plan targets drugs lacking biosimilar or generic option

12 September 2019 - While chances of her leaked plan to force lower drug prices in the United States getting through ...

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In U.S. biosimilars run into more roadblocks

12 September 2019 - In a recent op-ed in the Wall Street Journal Peter Bach asks whether it's time to ...

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We need to make biosimilars easier to get

11 September 2019 - If potential biosimilar manufacturers can’t get their product to market, they won’t proceed with development. ...

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Biosimilar and interchangeable: inseparable scientific concepts?

4 September 2019 - As defined by the European Commission, the term interchangeability refers to “the possibility of exchanging one medicine ...

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Canada OKs Celltrion's biosimilar

10 September 2019 - Celltrion said that Health Canada has given the go-ahead for Herzuma (trastuzumab), an anticancer antibody biosimilar, ...

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Erosion of physician and patient treatment choice continues - Alliance for Safe Biologic Medicines raises concerns for patients as British Columbia expands biologics forced switching policy

10 September 2019 - On 5 September, the Government of British Columbia announced that it would be forcibly switching 1,700 patients ...

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Health Canada updates its biosimilar fact sheet

4 September 2019 - Health Canada recently updated its fact sheet on biosimilars, including new or clarified information about key ...

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Mylan and Biocon get a second complete response letter for insulin glargine follow-on

3 September 2019 - Over the weekend, drug maker Biocon disclosed that it and partner Mylan have been issued a second ...

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Biosimilars Forum’s public letter in response to anti-biosimilars Op-Ed

29 August 2019 - Government Should Not “Throw In the Towel on Biosimilars,” They Should Act Now to Unlock Billions ...

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Dutch experience demonstrates effective benchmarking of biosimilar use in health systems

31 August 2019 - As medicines become more numerous and often more expensive, health care professionals seek new ways to understand ...

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EMA offers edits on FDA draft guidance on biosimilars

29 August 2019 - Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late ...

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Congress should be promoting, not discouraging, the development of biosimilars

27 August 2019 - Drug prices continue to dominate the headlines, yet many of the policy ideas being considered in ...

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We need a more rational biosimilars policy

27 August 2019 - Throwing in the towel on a whole new category of medicines, just shy of a decade in, ...

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Don’t give up on biosimilars—Congress can give them a boost

25 August 2019 - Drugs grown in live cells are hard to replicate. But policy changes can help accelerate the process. ...

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