Industry News

A Critical Analysis of the Final Guidance on Demonstrating Interchangeability of a Biosimilar With Its Reference Product - Sarfaraz K. Niazi, PhD
The FDA has issued its final guidance on demonstrating interchangeability of a biosimilar with its reference product to assist sponsors in showing that a proposed therapeutic protein product is interchangeable with a reference product for submitting a marketing application or supplement under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262[k]). In formulating the final guidance, the FDA had considered the comments provided in response to the invitation by the FDA when it posted draft guidance.
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Top 10 Drugs: Biologic Blockbusters And The Biosimilar Threat
INFOGRAPHIC: maturing cancer and autoimmune biologics still top the league for global revenues, but biosimilars are snapping at their heels.
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Novartis Battens Down Hatches Over Falsified Zolgensma Data
The Swiss major believes it responded in a timely fashion to data manipulation issues associated with its closely watched gene therapy but CEO Vas Narasimhan's bid to rebuild trust with society has taken a hit.
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Biosimilars Sponsors Seek Changes In US FDA Guidance On Comparative Analytical Assessments
Companies generally support decision not to require statistical equivalence testing but challenge agency’s skepticism about combining data from US and foreign reference products to set analytical similarity acceptance criteria.
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Is A Universal Flu Vaccine Still A Lifetime Away?
Influenza is a wily foe. It shows up each winter having taken a slightly different guise to outwit our existing immune defenses, but always keeps up its sleeve an ability to shapeshift to an entirely form that could crash straight through them.
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Inspection Data Reveals US/EU Mutual Recognition Agreement's Impact On China and India
Influenza is a wily foe. It shows up each winter having taken a slightly different guise to outwit our existing immune defenses, but always keeps up its sleeve an ability to shapeshift to an entirely form that could crash straight through them.
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