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17 APAC-Made Biosimilars Approved in the US or EU in 2026

Seventeen times in 2026, the US Food and Drug Administration or the European Commission cleared a biosimilar that was developed or made in Asia-Pacific. Ni...

October 27, 2026 | Analysis

Orphan Drug Incentives in 9 APAC Markets, Compared

Every January, regulatory affairs teams across Asia-Pacific rebuild the same spreadsheet. Which markets will designate this asset as an orphan? Which will ...

October 27, 2026 | Analysis

What Eight APAC Regulators Have Actually Published on AI in Drug Development

Ask a regulatory affairs lead in Tokyo, Seoul or Singapore what the rules are for using a machine learning model in a drug submission, and the honest answe...

October 22, 2026 | Analysis

FDA Warning Letters to APAC Drug Facilities in Fiscal 2026: The Full Ledger, Normalised

Every October, the same headline writes itself. India leads the count of US FDA warning letters to Asian drug plants, China follows, and the rest of the re...

October 21, 2026 | Analysis

How Long It Takes to Start a Clinical Trial in 8 APAC Markets, Timed

If you are building a 2027 trial budget this month, you are probably working from a spreadsheet with one row per country and a column headed "start-up". Mo...

October 19, 2026 | News

The PD-(L)1 x VEGF Bispecific Race: Every APAC Programme in the Clinic, Counted

When the ESMO Congress opens in Madrid on 23 October, one drug class will be hard to miss. Two days in, on the evening of Sunday 25 October, the Presidenti...

October 16, 2026 | Analysis

Semaglutide Generics, Six Months In: Every Launch in India, Every Price, and Where China Stands

AT A GLANCE 12 generic makers with a public launch in India, selling 20 brands between them Rs 1,290 lowest stated monthly price, for vials...

October 09, 2026 | Analysis

Every CAR-T Therapy Approved in Asia-Pacific, and What It Costs

Method in brief What counts. A CAR-T cell therapy approved on one of seven national registers: China's NMPA, Japan's PMDA and MHLW, Korea's MFDS, ...

October 08, 2026 | Analysis

From Academic Discovery to Biopharma Impact: Strengthening Southeast Asia’s Translation Pathway

Universities and public research institutes across the region are advancing research in cancer treatment, cell therapy, biologics and other emerging fields...

October 07, 2026 | Opinion | By Hajjerah TMK Hassan, Director, Discovery and Channels - ASEAN |Cytiva

12 Biotechs in Hong Kong's 18A Queue, and What Each Says It Will Spend the Money On

Every Hong Kong biotech applicant has to tell investors what it will do with the money it raises. On the evidence of the twelve 18A application proofs that...

October 07, 2026 | Analysis

APAC Biotech IPOs of 2026: Who Listed, What It Raised, Where It Trades Now

How this list was built Scope. Every biotech initial public offering with a first trading day between 1 January and 24 September 2026 on five venu...

September 29, 2026 | Analysis

The 10 Deals That Defined APAC Biopharma in 2026

The biggest pharma deals of 2026 with an Asia-Pacific principal are easy to list and hard to rank. The ten on this page carry more than US$70 billion in he...

September 25, 2026 | Analysis

Why 10,000 Koreans a Year Still Fly Abroad for Stem Cell Treatment

METHOD IN BRIEF This feature expands entry 21 of our year-end count, 2026 in 26 Numbers. Every figure is cited to a regulator publication, offi...

September 21, 2026 | Analysis

2026 in 26 Numbers: The APAC Biopharma Year, Counted

METHOD IN BRIEF A number qualifies for this list only if it is sourced to a company disclosure, regulator publication, exchange filing or peer-...

September 21, 2026 | Analysis

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