biosimilars

NEW TAIPEI CITY – November 08, 2026 -- GlycoNex (TPEx: 4168) has submitted a marketing authorization application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for SPD8, its denosumab biosimilar candidate, with approval possible as early as the end of 2027.

The timeline is subject to PMDA review. SPD8 was co-developed with Mitsubishi Gas Chemical (MGC). Preparations for a separate submission in Taiwan are also underway.

Phase 3 trial in 266 osteoporosis patients met its primary endpoint

The filing follows positive topline results from a randomized, double-blind, multicenter Phase 3 trial in Japan. The study enrolled 266 patients with osteoporosis. It demonstrated therapeutic equivalence to reference denosumab, measured by the percentage change from baseline in lumbar spine bone mineral density at Month 12.

Guangzhou – November 06, 2026 -- China's National Medical Products Administration (NMPA) has approved Bio-Thera Solutions' BAT2506, the first golimumab biosimilar cleared in the country, the Shanghai-listed company (688177.SH) said.

ASHULI is cleared for rheumatoid arthritis and ankylosing spondylitis

BAT2506 will be sold in China under the brand name ASHULI. The NMPA approved it for two indications: rheumatoid arthritis and ankylosing spondylitis.

Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-α). Binding to TNF-α reduces the inflammatory markers CRP, IL-6, ICAM-1, MMP-3 and VEGF.

Bio-Thera adds its sixth approved biosimilar in China

CEO Shengfeng Li said ASHULI is the company's sixth biosimilar approved in China. He said biosimilars "have an important role in expanding patient access to important biologics."

BAD HOMBURG – – November 02, 2026 -- Fresenius has secured exclusive rights to up to 37 biosimilar candidates under a development agreement with WuXi Biologics. The company calls it the largest development agreement announced in the biosimilars industry to date. The deal could lift Fresenius' portfolio from 29 marketed and pipeline molecules today to as many as 66 over the next decade, addressing more than €370 billion in originator list-price-based sales.

Fresenius keeps full commercial economics and selection control

Fresenius will hold exclusive global commercialization rights, including marketing authorizations, and the full economics of each commercialized product. It will select and advance candidates against three criteria: market attractiveness, development risk and expected returns. Development is expected to run through WuXi Biologics' network across Europe, the United States, China and Singapore.

Madrid – September 20, 2026 -- mAbxience and Sandoz have signed a licensing, development, manufacturing and commercialization agreement for a proposed emicizumab biosimilar targeting hemophilia A, a treatment referencing Roche's Hemlibra with an estimated global reference market of USD 5.7 billion.

mAbxience will develop and manufacture the biosimilar at GMP facilities in Spain and Argentina

Under the agreement, mAbxience is responsible for development and manufacturing through its facilities in the two countries. Sandoz will handle global commercialization.

Sandoz secures exclusive global rights excluding three South American markets

Sandoz holds exclusive commercialization rights worldwide, with the exception of Argentina, Uruguay and Paraguay. Financial terms of the deal were not disclosed.