Category Archives: Biologics/Biosimilars

U.S. Supreme Court agrees to hear dispute over biologic drug sales

By Andrew Chung, Reuters The U.S. Supreme Court on Friday agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them. The justices will … Continue reading

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Swiss drugmaker Roche launches costliest cancer drugs in India

Economic Times, November 26, 2015. Mumbai: As insurers, patients and governments across the world debate over the rising cost of healthcare, Swiss pharmaceutical major Roche has boldly launched two new drugs for late-stage breast cancer, pricing them higher than any other … Continue reading

Posted in Biologics/Biosimilars, Cancer, Pricing | Leave a comment

Physicians call for fairness in drug prices, availability

American Medical Association, November 17, 2015. In response to increasing drug costs impacting patient access to needed medications, physicians voted Monday at the 2015 Interim Meeting to convene a task force and launch an advocacy campaign to drive solutions and help … Continue reading

Posted in Anti competition, Biologics/Biosimilars, Transparency | Leave a comment

WikiLeaks Publication of Complete, Final TPP Intellectual Property Text Confirms Pact Would Raise Costs, Put Medicines Out of Reach

Source: Public citizen Oct 9, 2015 WikiLeaks’ publication today of the final Trans-Pacific Partnership (TPP) Intellectual Property chapter text verifies that the pact would harm public health by blocking patient access to lifesaving medicines, Public Citizen said today. The latest … Continue reading

Posted in Biologics/Biosimilars, Data Exclusivity, Evergreening, Patent Term Extension, TPP, TPP | 1 Comment

Decision Time On Biologics Exclusivity: Eight Years Is No Compromise

Source: IP Watch 30 July 2015 As the Trans-Pacific Partnership (TPP) negotiations approach their endgame, biologics exclusivity is still considered “one of the most difficult outstanding issues in the negotiation.”[2] Pharmaceutical companies seek longer data and marketing exclusivities to further delay … Continue reading

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For First Time, F.D.A. Panel Approves Generic Copy of Costly Biologic Drug

Source: New York Times 9 Jan 2015 SILVER SPRING, Md. — An expert panel unanimously recommended on Wednesday that the Food and Drug Administration approve a cheaper copy of a special drug used in cancer therapy, paving the way for … Continue reading

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Going large

Source: The Economist 6 Jan 2015 A wave of new medicines known as biologics will be good for drugmakers, but may not be so good for health budgets IN PHARMACEUTICALS, the 20th century was the era of the small molecule. … Continue reading

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