Lotus Pharmaceutical Becomes Commercialization Partner For Formycon's Keytruda Biosimilar Candidate FYB206 Across Major Parts Of The Asia-Pacific Region

Formycon AG and Lotus Pharmaceutical (“Lotus”) today announced the conclusion of an exclusive license agreement for Formycon’s Keytruda ⁽¹⁾ biosimilar candidate FYB206 (Pembrolizumab). Lotus, a multinational pharmaceutical company with a strong presence in Asia and a diverse portfolio of novel, generic and biosimilar medicines will commercialize FYB206 across major parts of the Asia-Pacific (“APAC”) Region.

Upon signature of the agreement, Formycon will receive an upfront payment and will be eligible for further payments contingent on the achievement of certain development and regulatory milestones. In addition, Formycon will receive a share of the gross profits upon market launch in the region and will be responsible for the manufacturing and supply of the finished product.

“The addition of this important oncology therapeutic to our existing partnership with Lotus underscores our well-established and trusted collaboration and marks another important step in Formycon’s global commercialization strategy. Lotus has a unique footprint in the APAC region. Together we aim to broaden patient access to effective and cost‑efficient treatment options for serious diseases while creating sustainable long-term value”, said Nicola Mikulcik, CBO of Formycon AG.

Petar Vazharov, CEO of Lotus Pharmaceutical, commented: “We are pleased to expand our collaboration with Formycon through this agreement for FYB206, a highly important biosimilar candidate in oncology. Biosimilars represent a key growth pillar for Lotus, and pembrolizumab is among the most clinically impactful and widely used biologics globally. By combining Formycon’s development expertise with Lotus’ strong commercial platform across Asia-Pacific, we aim to improve patient access to high-quality, cost-effective biologic therapies while further strengthening our specialty oncology portfolio in the region.”

FYB206 is approaching the end of its clinical development phase, with primary endpoint data expected in the first quarter of 2026. Following completion of the data package, Formycon and Lotus will closely align to prepare the regulatory submissions in the APAC countries according to the local requirements.

Pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology and global sales of US$ 31.7B in 2025⁽²⁾, Keytruda is currently one of the world’s best-selling drugs, underscoring the substantial oncology demand and market potential across the world. According to market research estimates, sales in the Asia-Pacific region could amount to approximately $7.0B in 2025^(3).

About Formycon
Formycon AG is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

For more information, visit https://www.formycon.com/

About Lotus
Founded in 1966, Lotus is a global pharmaceutical company focused on novel and generic drugs, providing better, safer, and more accessible medicines. With a top-tier R&D and manufacturing platform in Asia, Lotus has partnerships in major markets including the U.S., Europe, Japan, China, and Brazil. The company manages over 100 strategic projects in Asia and the US, with a portfolio exceeding 250 commercial products. Lotus invests in a diverse portfolio of high-barrier oncology treatments, complex generics, 505(b)⁽²⁾, and NCE drugs through internal R&D and licensing. It also strengthens its competitiveness with biosimilars, supported by strategic partners. Its infrastructure is certified by leading regulatory authorities, including the US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA. For more information, visit https://www.lotuspharm.com/

About Biosimilars
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

¹ Keytruda is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.

² https://www.merck.com/news/merck-highlights-progress-advancing-broad-diverse-pipeline/

³ https://www.grandviewresearch.com/horizon/outlook/keytruda-market/asia-pacific