News
Overview of clinical research on generics in 2012
2013-01-09 Period: January to August 2012 Generic drug alternatives to brand-name prescription medications are becoming increasingly important in the global drug market as governments strive to… Read More »
EMA approves first generic imatinib
2013-01-07 EMA’s Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2012 that the agency had approved a generic version of imatinib. Imatinib… Read More »
Glossary of key terms
2013-01-01 Last update: 13 February 2015 Confusion may sometimes surround terms used in the fields of generics and biosimilars. This has been recognized as a problem by… Read More »
MSF launches online ‘Patent Opposition Database’
2012-12-27 The international medical humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF) has launched an online resource to help civil society and patient groups in developing countries… Read More »
Momenta versus Amphastar and the safe harbour provision
2012-12-25 On 3 August 2012, the US Federal Circuit issued a decision holding that the safe harbour* provision of the Hatch-Waxman Act 35 U.S.C. § 271(e)(1)… Read More »
Generic drug user fees come into effect
2012-12-20 Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (GDUFA) was approved by the US Congress’s House… Read More »
Generic medicine switches confuse patients and reduce adherence
2012-12-18 Switching between generic medicines without explaining the reason to the patient can undermine trust in pharmacists, the Aston Medication Adherence Study (AMAS) has found. The… Read More »
India plans further cuts to drug prices
2012-12-12 The Indian government has announced plans to further extend price cuts on both generic and brand-name drugs in order to try to improve access to… Read More »
FDA gives generics greater importance
2012-12-10 The Office of Generic Drugs has been promoted to the highest position within FDA because of the great amount of work and income/expenditure now associated… Read More »
Overview of research on biosimilarity/comparability and interchangeability of biosimilars 2012
2012-12-07 Period: January to August 2012 After the patent on a biological medicine expires ‘similar’ versions of the originator biological can be produced. These biosimilars or… Read More »
