Pharma and Healthcare Insight

Pharma & Healthcare Insight brings you analysis of regional trends, regulatory changes, projects and investments plus competitive intelligence on the growth strategies of leading companies in the sector

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Key stories from this month's issue...

Industry Trend Analysis - Biosimilar Market Threatened By Current Market Practices - APR 2018

Americas April 2018 / United States / Industry

The FDA has emphasised a mission to improve regulatory processes in order to facilitate competition to drive down prices, but has consistently noted that it has no power over pricing. Commissioner Scott Gottlieb's speech to the AHIP Conference is notable for taking aim at pricing practices and his allegation that current models will not allow a biosimilar market to flourish is a clear warning. Whilst market consolidation amongst payors has compounded the situation in his view, this also means that it will only require a few players to change practices to make a significant difference.

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Industry Trend Analysis - Merck KGaA Well Poised For Emerging Market Growth Following Continuous Investments - APR 2018

Asia April 2018 / China / Industry

Merck KGaA will continue to expand and diversify the company's commercial operations in China and the pharmaceutical company will maintain its commitment towards healthcare initiatives in the country. New regulatory pathways and improvements to the country's intellectual property protection environment will work to ease the commercialisation bottlenecks, bolstering long term growth opportunities for drugmakers.

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Industry Trend Analysis - EAEU Regulatory Harmonisation To Boost Drugmaker Prospects - APR 2018

Emerging Europe April 2018 / Kyrgyzstan / Industry

Kyrgyzstan's nascent regulatory environment presents risks to drugmakers. The implementation of price controls will improve access to medicines while stabilising market dynamics, and the transition towards adopting unified legislation for the Eurasian Economic Union will also increase regulatory transparency and access to medicines. We note that these legislative changes remain in the draft and development stage and as such little impact will be felt in the short term.

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Industry Trend Analysis - Agreement Strengthens Pharco As An HCV Regimen Supplier - APR 2018

Middle East & Africa April 2018 / Argentina / Industry

Pharco Pharmaceuticals is strengthening its position as a supplier of hepatitis C drugs for the developing world and this agreement sees it broaden its reach from the Middle East and Asia into Latin America. From an intellectual property aspect, the key element of this agreement will be sofosbuvir, and specifically how Gilead responds. The company will be aware of the danger this agreement presents that Malaysia's compulsory licensing move will broaden into new territories, but the company has so far employed a relatively gentle touch regarding access to affordable sofosbuvir.

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Industry Trend Analysis - EMA Approval Race Underway For Biosimilar Pegfilgrastim - APR 2018

Western Europe April 2018 / Europe / Industry

Gedeon Richter is in a regulatory race with Sandoz (Novartis) for the first biosimilar pegfilgrastim product to be approved in the EU. However, both companies have suffered regulatory setbacks with their applications, highlighting the difficulties pegfilgrastim presents for biosimilar manufacturers. Gaining first-to-market status will be important for either firm, but Amgen's branded sales are declining in the EU; this will further diminish the likely returns for any biosimilars.

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