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Biosimilars

  • Biosimilars pathway safe after US Supreme Court upholds Obama healthcare

    June 28, 2012

    The US Supreme Court has upheld so-called Obamacare, ensuring that the pathway for biosimilars included with the law will remain intact

  • The US approach to biosimilars explained

    February 15, 2012

    The FDA’s draft guidance for biosimilars has provided some clarity for biosimilar applicants and innovator biologic companies. But lawyers say many questions remain

  • FDA adopts European approach to biosimilars

    August 17, 2011

    The Food and Drug Administration has shed some light on its approach to assessing biosimilars in a recent article published in the New England Journal of Medicine

  • Stakeholders brace for first biosimilar application

    June 30, 2011

    Innovator companies and potential biosimilar applicants have expressed reservations about the new US scheme for biosimilar approval, which became law in March last year

  • Europe issues biosimilar-friendly guidelines

    December 01, 2010

    Guidelines for the production of biosimilar antibody drugs in Europe released last week focused on safety rather than efficacy, setting a lower hurdle than had been feared

  • Be prepared for biosimilars

    November 01, 2010

    A new US law has paved the way for biosimilar drugs. Janice A Vatland, Michael T Siekman and Chelsea A Loughran explain what pioneer and biosimilar manufacturers need to know

  • Blow to biosimilars in amended US health care act

    July 16, 2009

    A US Senate committee adopted an amendment to health care legislation on Monday night that will give 12 years of data exclusivity to innovative biologics

  • EU Bolar exemption is not so simple

    September 01, 2008

    The EU directive to introduce a US-style Bolar provision promised to harmonise the law on clinical trials. But, says Marina Barnden, inconsistent application has led to uncertainty

  • Biosimilar debate heats up at BIO

    June 18, 2008

    Speakers at the 2008 BIO International Convention in San Diego yesterday discussed the regulatory and scientific issues created by generic biological drugs, commonly known as biosimilars or follow-on biologics

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