Samsung Bioepis is expanding in the US biosimilars market, with ten FDA approvals so far, seven assets in development, and an ambitious target of 20 products on the market by 2031. Tom Newcomer, SVP and Head of US Commercial, sets out why quality and supply reliability, rather than low prices, are at the heart of…
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Korea, the world’s 13th-largest pharma market, is rolling out its biggest reform to pharma pricing in a generation, slashing what it pays for generics and using the savings to get innovative medicines to patients faster and at better prices. The same squeeze on generic margins, combined with new rewards for R&D, aims to push domestic…
16 years ago, China accounted for less than eight percent of the world’s clinical trials. Today it hosts more than any other country. This story – of patient populations, regulatory frameworks, and biotech ecosystems that were once peripheral to global drug development becoming central to it – is being repeated across Asia. But scale and…
LatAm Real-World Data in Healthcare Technology Incorporation: A Strategic Opportunity for Latin America
Real-world evidence (RWE) is now a regular part of health technology assessment in Europe and North America. In this article, first published in ISPOR’s Value & Outcomes Spotlight (July/August 2026), authors from six of ISPOR’s Latin American chapters argue that the region has plenty of health data. What it lacks is the governance, interoperability and…
In Conversation
Donghoon Lee – CEO, SK Biopharmaceuticals
“ We are no longer a purely Korean company; our ambition is to become a genuinely global player in epilepsy ”
Ingeborg Borgheim – General Manager, Takeda Germany
“ I am confident that Germany will continue to offer the right conditions for long-term innovation and growth ”
Petar Vazharov – CEO, Lotus Pharmaceutical
“ We have transformed ourselves into a top 20 specialty pharmaceutical company globally ”
Michala Fischer-Hansen – EVP & Head of Europe & International Markets, Lundbeck
“ If we want Europe to remain a place where innovation arrives early rather than late, we need to work together ”
Mario Rovirosa – CEO, Ferrer
“ We are not here to maximise return on investment; we want to remain sustainable while doing something meaningful ”
Seulki Lee – Founder & CEO, D&D Pharmatech
“ Our vision remains very simple: to turn great science into medicines that can change patients' lives ”
Sarah Yim – Director, Office of Therapeutic Biologics and Biosimilars, CDER, FDA
“ My goal, and the FDA goal in general, is to make regulatory expectations so efficient that developers are willing to pursue biosimilars for non-blockbuster biologics. ”
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InFocus
China has rapidly become the world’s leading country for clinical trial volume, alongside the stratospheric growth of its local biotech industry, which now accounts for almost a third of the global drug development pipeline. The high speed and low cost of Chinese trials are unmatched globally. However, in a volatile geopolitical environment and with some…
Korea’s position as a clinical trials hub did not happen overnight. The country has treated clinical development as a matter of deliberate government policy for the better part of two decades, with Korea ranking among the world’s leading trial destinations as far back as 2018; years before China’s biotech ambitions fully took off. That sustained…
Taiwan’s population of just 23 million people and contested political status should, in theory, harm its chances of becoming a globally relevant clinical trials hub. In fact, these two factors – which have forced the island to adopt the most rigorous international standards and build a dense web of global partnerships – might ultimately be…
Japan is resetting itself as a clinical trial destination. Costs have halved, local data requirements are being relaxed, and the country is actively courting the global biotechs that have long overlooked it for trials. The opportunity is real; but so is the ground Japan still must make up. Japan’s importance to the global biopharmaceutical…
