Category Biodiversity/Genetic Resources/Biotech

Special Report: The Battle For Biosimilars In India

[story updated] Biosimilar drugs hold out big opportunities for India’s drug companies. But the future is fraught with challenges. One key challenge is regulations.

What does this mean for countries like India, an emerging market for biosimilars? How will the evolving global regulatory environment on biosimilars impact patients?

Last month, both these questions came to the fore as the battle over biosimilars moved centre stage in this country in the wake of an interim order by the Delhi High Court, and then another decision by a Division Bench of the same court which took a different view.

Drawn Out Battle Over Genetic Resources Dampens Africa’s Hopes

Chidi Oguamanam writes: The global South is full of significant, diverse biological and genetic resources. It’s also home to most of the world’s indigenous communities. This is why developing countries are sensitive about protecting their genetic resources and traditional knowledge.

Indigenous communities enjoy a close relationship with nature. Genetic resources are central to producing their traditional knowledge. This drives innovations in agriculture, medicines and conservation. But global intellectual property frameworks – the legal mechanisms for securing knowledge ownership – still haven’t taken this reality into account.

Review Of WHO Pandemic Flu Preparedness: Data Sequencing And Other Issues

Five years after its adoption, a World Health Organization mechanism to help the world be ready for future influenza pandemics is being reviewed. According to several stakeholders invited to share their views, a major challenge is genetic sequence data, which allows digital reproduction of material. Other issues include the relationship of the mechanism to an international convention on access to genetic resources, and the contribution of industry.

Biotherapeutic Medicines, A New Frontier, Face Regulatory Issues

Biotherapeutic medicines, engineered by living organisms, have opened a promising path to treat major diseases. Near copies of these medicines, called biosimilars, are slowly coming to market, as the originator products become free of intellectual property rights or data protection.

However, some regulatory issues are left to be addressed, in particular in developing countries, according to the pharmaceutical industry and the World Health Organization. For patients, information on those products and their affordability are key, said a patient group representative.

Geographical Indications In The TTIP: Faites Vos Jeux

Ever heard of Törkölypálinka? It is a Hungarian grape marc spirit and one of approximately 200 geographical origins listed by the European Commission negotiators of the Transatlantic Trade and Investment Partnership (TTIP). In their newly published proposals, the EU negotiators laid out their ideas on GI protection in the deal, and point to an earlier EU-US agreement with regard to GI protection of wines and spirits. But they also acknowledge the need for considerable bridging between the two systems. GI protection is expected to be one of the highly controversial issues in the “end game” of TTIP.

Status Quo For WIPO Committee On Genetic Resources; Dialogue Ongoing To Unlock It

The amiable mood which prevailed at the outset of the World Intellectual Property Organization committee on genetic resources and traditional knowledge meeting did not hold as negotiations on language of a potential treaty text to prevent misappropriation of genetic resources unearthed vivid divisions on the way to achieve such prevention. In addition, the participation of indigenous peoples is jeopardised by lack of funds, and the committee called for governments to help.