Zydus and Formycon enter into an Exclusive Partnership for the Licensing and Supply of Biosimilar to Keytruda® (Pembrolizumab), in US and Canada

Rhea-AI Summary

Zydus Lifesciences and Formycon entered an exclusive partnership on Dec 9, 2025 for the licensing and supply of FYB206, a biosimilar to Keytruda (pembrolizumab), for the USA and Canada.

Formycon will develop, register, manufacture and supply FYB206 while Zydus Lifesciences Global FZE will handle commercialization in the defined territories. A BLA application is expected to be submitted to the US FDA in the near future. The announcement notes this marks Zydus' entry into the North American biosimilar market and references a proposed acquisition of Agenus manufacturing facilities in California to support future manufacturing integration.

Positive

• Exclusive US/Canada license and supply for FYB206 announced on Dec 9, 2025
• Formycon to develop, register, manufacture and supply FYB206
• Zydus to commercialize FYB206 in USA and Canada
• BLA application for FYB206 expected to be submitted to US FDA

Negative

• FYB206 requires BLA approval before US commercialization
• Zydus will depend on Formycon for development and manufacturing
• Referenced Agenus facility acquisition is proposed and not completed

Market Reality Check

$96.89 Last Close

Volume Volume 12,670,250 is below the 20-day average of 15,774,599 (volume_relative 0.8). normal

Technical Price 98.93 is trading above the 200-day MA at 84.87 and 6.53% below the 52-week high of 105.84.

Peers on Argus

Peers show mixed moves: AZN up 1.01% while NVO, NVS, ABBV and JNJ are down between 0.51% and 2%, suggesting stock-specific dynamics for MRK rather than a unified sector trend.

Common Catalyst Multiple large-cap pharma peers (AZN, JNJ) also reported oncology-focused clinical trial updates today, indicating a broader oncology news flow rather than a single-company catalyst.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 04	Animal health approval	Positive	-1.4%	Conditional FDA approval for EXZOLT CATTLE-CA1 in cattle parasites.
Dec 01	Alzheimer’s data	Positive	-2.9%	Phase 1 data and Fast Track designation for MK-2214 plus MK-1167 update.
Nov 26	Investor conference	Neutral	-1.0%	Participation announcement for Citi 2025 Global Healthcare Conference.
Nov 26	Investor conference	Neutral	-1.0%	Participation in Evercore ISI HealthCONx healthcare conference fireside chat.
Nov 24	Hematology pipeline	Positive	+2.7%	ASH 2025 hematology data presentations across several investigational programs.

Pattern Detected

Recent MRK news skew positive (approvals, pipeline data, conferences), yet 4 of the last 5 events saw negative next-day price reactions, suggesting a pattern of selling into good news.

Recent Company History

Over the last few weeks, MRK has highlighted multiple pipeline and regulatory milestones. On Nov. 24, it outlined hematology data to be presented at ASH 2025, which coincided with a +2.7% move. Subsequent conference participation announcements on Nov. 26 and Alzheimer’s data showcased on Dec. 1 were followed by declines of 0.97% and 2.86%, respectively. A conditional FDA approval for EXZOLT CATTLE-CA1 on Dec. 4 also saw a 1.35% drop. Against this backdrop, today’s Keytruda biosimilar partnership by competitors adds competitive overhang to MRK’s key oncology franchise.

Market Pulse Summary

This announcement highlights an exclusive partnership for a biosimilar to Keytruda in the US and Canada, underscoring emerging competition around a major oncology therapy. MRK’s shares were trading at 98.93, above the 200-day MA of 84.87 and about 6.53% below the 52-week high, with below-average volume. Recent history shows several positive or neutral MRK updates followed by price weakness, and regulatory filings reveal ongoing debt issuance and insider net selling, key context for evaluating competitive news flows.

Key Terms

immunotherapy medical

"is aimed at making immunotherapy affordable and accessible to patients in need"

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

AI-generated analysis. Not financial advice.

AHMEDABAD, India and PLANEGG-MARTINSRIED, Germany, Dec. 9, 2025 /PRNewswire/ -- Zydus Lifesciences Limited (including its subsidiaries and affiliates), an innovation-led life-sciences company, with an international presence, today announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates has entered into a strategic partnership with Formycon AG for the exclusive licensing and supply of checkpoint inhibitor FYB206, a biosimilar of Keytruda®¹ (Pembrolizumab) in the USA and Canada market.

Under the terms of this agreement, Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories. The BLA application is expected to be submitted to the USFDA in the near future and is aimed at making immunotherapy affordable and accessible to patients in need.

Commenting on this strategic partnership, Managing Director of Zydus Lifesciences Limited, Dr. Sharvil P. Patel, stated, "We are happy to collaborate with Formycon to develop and commercialize a biosimilar of Keytruda® across US and Canada. This venture marks Zydus' entry into the North American biosimilar market, debuting with an immunotherapy product. This collaboration also complements Zydus' recent proposed acquisition of Agenus Inc.'s California, USA based manufacturing facilities, which we plan to integrate and leverage for manufacturing in the future. By combining our expertise and resources, we aim to drive significant organizational growth and deliver maximum value to patients through expanded access to affordable oncology care."

Dr. Stefan Glombitza, CEO of Formycon, stated, "FYB206, a biosimilar of Keytruda®, demonstrates Formycon's advanced expertise in developing biosimilar medicines for highly regulated countries. Partnering with Zydus, an organization recognized for its regulatory proficiency and commercial presence, enables us to deliver this important therapeutic option to the patients. This collaboration strengthens our collective commitment to expanding access to medicines."

About Zydus Lifesciences Limited

Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 27,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details, visit www.zyduslife.com.

About Formycon

Formycon AG (FSE: FYB) 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.

Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com/.

^{1) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, (NYSE: MRK) Rahway, NJ/USA.}

Logo: https://mma.prnewswire.com/media/2592545/5350910/Zydus_Lifesciences_Limited_Logo.jpg

 

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SOURCE Zydus Lifesciences

FAQ

What did Zydus and Formycon announce on Dec 9, 2025 about FYB206 (biosimilar to Keytruda) for MRK investors?

They announced an exclusive partnership for licensing and supply of FYB206 in the USA and Canada, with Formycon handling development and manufacturing and Zydus handling commercialization.

Will Zydus submit a BLA for FYB206 to the US FDA and when will it happen?

The press release states a BLA application is expected to be submitted to the US FDA in the near future; no specific date was provided.

Who will manufacture FYB206 and who will commercialize it in the USA and Canada?

Formycon will develop, register, manufacture and supply FYB206; Zydus Lifesciences Global FZE will commercialize it in the defined territories.

Does this partnership change Zydus' presence in North America and how?

Yes; the announcement describes this as Zydus' entry into the North American biosimilar market, debuting with an immunotherapy product.

How does the proposed Agenus facility acquisition relate to the FYB206 partnership?

Zydus said the proposed acquisition of Agenus manufacturing facilities in California would be integrated and leveraged for manufacturing in the future.