The US Supreme Court has upheld so-called Obamacare, ensuring that the pathway for biosimilars included with the law will remain intact
The FDA’s draft guidance for biosimilars has provided some clarity for biosimilar applicants and innovator biologic companies. But lawyers say many questions remain
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
Innovator companies and potential biosimilar applicants have expressed reservations about the new US scheme for biosimilar approval, which became law in March last year
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
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
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
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
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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