The International Generic and Biosimilar Medicines Association (IGBA) welcomes the adoption by the International Council for Harmonization (ICH) of a new topic proposal on Bioequivalence for ImmediateRelease Solid Oral Dosage Forms (M13)i . The ICH Assembly approved the Concept Paper Outline in their November Singapore meeting with the establishment without delay of a new Working Group to initiate work on finalizing the concept paper and business plan for this new topic.
Since September 2018 the World Intellectual Property Organization (WIPO) has hosted the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) patent database Pat-INFORMEDi on its website. This database is simply a posting of unverified patent information provided directly by originator pharmaceutical companies. WIPO specifically exempts itself and IFPMA member companies from any and all liability for the provision of false or inaccurate informationii .
Full access to medicines is hampered by a variety of factors. Two important barriers are high prices and regulatory issues such as long lag times in bringing medicines to market.
- IGBA recommendations for action to support a sustainable global pharmaceutical market for continued patient access worldwide to safe, effective and high-quality medicines (October 2019)
- The positive impact that generic and biosimilar medicines have on patients and health systems (October 2019)
- Op-ed: Trade agreement drug monopoly is obsolete given faster, better drug discovery
- IGBA Releases Trade Principles to Foster Trade in Generic and Biosimilar Medicines