The Global Division of Labor Behind the Coming Oncology Biosimilar Wave

Key Takeaways
Qilu will handle development, regulatory registration, manufacturing, and supply of the proposed pembrolizumab biosimilar QL2107, while Cipla USA will manage U.S. commercialization.
QL2107 is in phase III development, with a registered comparative study against Keytruda that began in January 2025.
Formycon uses separate commercialization partners for FYB206 in North America and major Asia-Pacific markets while retaining significant technical and supply responsibilities.
Alvotech and Dr. Reddy’s use a different model in which development and manufacturing responsibility for their pembrolizumab biosimilar candidate is shared.
FDA guidance continues to tie biosimilar applications closely to CMC and manufacturing-site information, even as 2026 draft guidance may reduce certain duplicative pharmacokinetic requirements involving non-U.S.-licensed comparators.

A New Kind of Biosimilar Partnership

When Cipla subsidiary InvaGen Pharmaceuticals announced a strategic partnership with Qilu Pharmaceutical in September 2026 for QL2107, Qilu’s proposed biosimilar to Keytruda (pembrolizumab), the agreement divided responsibility for the product along unusually clear lines. Qilu will handle development, regulatory registration, manufacturing, and supply, while Cipla USA will commercialize the product in the United States.^1,2

The structure is more revealing than a conventional licensing arrangement. It allows the organization advancing and manufacturing the biosimilar to rely on a separate U.S. commercial partner, while the commercial organization can enter the opportunity without having originated the development and manufacturing program. The partners connect capabilities that sit in different organizations within a single route to market.

QL2107 is already in phase III development. A Qilu-sponsored randomized, double-blind study is comparing QL2107 with Keytruda, each in combination with chemotherapy, in patients with metastatic non-squamous non-small cell lung cancer. The registered study began in January 2025, has an estimated enrollment of 808 participants, and lists estimated completion in December 2026.³

The Cipla–Qilu arrangement therefore offers an early look at an operating model that could become increasingly relevant as high-value oncology biologics approach biosimilar competition. The question is how responsibility is divided across development, manufacturing, regulatory work, supply, and commercialization, and how those functions remain connected when no single organization controls the entire chain.

Why Pembrolizumab Is the Test Case

Few biosimilar opportunities make those questions as consequential as pembrolizumab. Merck reported $31.68 billion in 2025 sales for Keytruda and Keytruda Qlex, giving prospective competitors an unusually large reference-product market to pursue.⁴

The timing of competition, however, is more complicated than a single patent-expiration date. Merck has said that the Keytruda compound patent expires in December 2028, while a method-of-making patent extends to May 2029 and a method-of-use patent extends to November 2029. Merck has described the potential period of protection as extending into 2029 while continuing to use 2028 for planning purposes.⁵

Companies are already building development and commercial arrangements around that future opportunity. QL2107 is one example, but other pembrolizumab biosimilar programs illustrate different ways to allocate responsibilities among partners.

Formycon and Zydus entered an agreement covering FYB206 in the United States and Canada under which Formycon will complete development, prepare and file the regulatory dossier, and supply the product, while Zydus will handle commercialization. Formycon separately partnered with Lotus Pharmaceutical for commercialization of FYB206 across major parts of the Asia-Pacific region while retaining responsibility for manufacturing and supplying finished product.^6,7

Alvotech and Dr. Reddy’s Laboratories have adopted a different structure for their proposed pembrolizumab biosimilar. Their agreement makes the companies jointly responsible for development and manufacturing, including shared costs and responsibilities, while each retains commercialization rights subject to stated exceptions.⁸

The same reference product is therefore giving rise to markedly different partnership structures. That makes pembrolizumab useful as both a major biosimilar opportunity and a case study in how companies are assembling the capabilities needed to pursue one. Because these arrangements are forming before potential U.S. competition begins, they also reveal how much organizational work precedes commercialization. The eventual competitive landscape will reflect decisions about development ownership, manufacturing, supply, regulatory responsibility, and regional commercialization that are being made years before products may reach the market.

Dividing the Biosimilar Value Chain

Cipla–Qilu makes the division particularly easy to see because the agreement concentrates most technical responsibilities with Qilu and U.S. commercialization with Cipla. Qilu advances development, handles regulatory registration, manufactures the product, and supplies it; Cipla USA takes responsibility for commercialization in the United States.^1,2

The significance lies in the separation itself. Development, manufacturing, regulatory responsibility, supply, and commercialization do not all have to sit inside the same organization. In the Cipla–Qilu model, most of the technical work remains concentrated with one partner, while another provides the commercial route into the target market.

That distinction changes what a “biosimilar company” may represent in practice. The organization whose name is most visible in a particular market may not be the organization that developed or manufactured the product, and the developer may have little reason to reproduce the same commercial structure in every territory. The asset instead becomes the connecting point among organizations with different responsibilities. Cipla–Qilu is especially useful as a case because the announced allocation is explicit enough to see where one set of responsibilities ends and another begins.

Formycon’s FYB206 arrangements extend that logic geographically. For the United States and Canada, Formycon retains development, regulatory-dossier, submission, and supply responsibilities while Zydus commercializes the product. In major Asia-Pacific markets, Lotus serves as the commercialization partner while Formycon retains manufacturing and supply.^6,7

That structure provides a different model: substantial technical responsibility remains with the developer while commercialization is assigned by territory. The same candidate can therefore sit behind different regional partnerships without requiring the underlying development and supply responsibilities to move with each commercial agreement.

The comparison with Cipla–Qilu is instructive. Both arrangements separate commercialization from much of the technical work, but Formycon’s agreements show that the commercial layer itself can be divided geographically. Zydus is responsible for commercialization in the United States and Canada, while Lotus holds that role across major parts of Asia-Pacific. Formycon remains responsible for supply in both arrangements and for manufacturing the finished product in the Lotus agreement. The resulting structure is less a single bilateral partnership than a set of territorial relationships built around the same candidate.

Alvotech and Dr. Reddy’s illustrate another approach. Their collaboration distributes responsibility earlier in the value chain because development and manufacturing themselves are shared.⁸

These agreements span a spectrum. Cipla–Qilu separates technical execution from U.S. commercialization. Formycon combines retained development and supply responsibility with different regional commercial partners. Alvotech and Dr. Reddy’s share core technical responsibilities.

That spectrum matters because each structure places the coordination boundary in a different location. In Cipla–Qilu, the clearest boundary falls between technical execution and commercialization. In the Formycon arrangements, it falls between a relatively centralized technical base and multiple territorial commercial relationships. In Alvotech–Dr. Reddy’s, some of the coordination burden moves upstream because development and manufacturing are joint responsibilities. Those differences do not establish that one model is superior, but they make the partnership structure itself a strategic variable rather than a secondary feature of the program.

The structures also create different dependencies. Where commercialization and supply sit with separate organizations, commercial execution depends on technical and supply performance outside the commercial partner’s direct control. Where development and manufacturing are shared, the partners instead have to coordinate those activities jointly. These are analytical implications of the documented structures rather than disclosed terms of the agreements, but they point to an important question for biosimilar strategy: which functions should remain concentrated, which can be divided, and where does shared responsibility add value rather than complexity?

The Regulatory and Operational Catch

A distributed organizational structure does not make the product itself divisible from a regulatory perspective. The U.S. Food and Drug Administration’s (FDA) September 2025 final guidance on comparative analytical assessment and other quality considerations addresses the chemistry, manufacturing, and controls (CMC) information included in applications submitted through the biosimilar pathway.⁹ FDA guidance also calls for applications to identify the manufacturing, packaging, and control sites associated with the drug substance and drug product.¹⁰

That places a practical constraint on distributed operating models. Responsibilities may reside with separate companies, but the information supporting the product, manufacturing network, and regulatory submission still has to remain connected. A commercial agreement can divide organizational responsibility; it does not remove manufacturing and CMC from the regulatory package.

This is where the division-of-labor model becomes more demanding than the deal announcement may initially suggest. The commercial and technical roles can be separated contractually, but the product presented to regulators still rests on a defined body of analytical, manufacturing, and facility information. The practical value of specialization therefore depends on coordination across the boundaries the partnership creates. The more functions are distributed, the more important it becomes that those boundaries do not fragment the information supporting the regulated product.

The regulatory framework is also changing in a way that could reduce some duplication in globally organized development programs. In March 2026, the FDA issued draft guidance describing scenarios in which clinical data generated using a non-U.S.-licensed comparator could support a U.S. biosimilar application without additional data from a three-way pharmacokinetic study involving the proposed biosimilar, the U.S.-licensed reference product, and the non-U.S.-licensed comparator.¹¹ The agency also removed its earlier recommendation for at least one clinical pharmacokinetic study directly comparing the proposed biosimilar with the U.S.-licensed reference product, allowing a comparator approved outside the United States to be used when scientifically justified.

The guidance remains draft, and it does not remove U.S. regulatory requirements. It could, however, reduce one source of duplicated work when development relies on a non-U.S.-licensed comparator

For distributed partnerships, the distinction is important. Certain data generated with a non-U.S.-licensed comparator may be usable in support of a U.S. program under the scenarios described by the FDA, while the manufacturing and quality information associated with the application remains integral to regulatory review. The opportunity to distribute work therefore does not eliminate the need to keep the resulting development, manufacturing, and regulatory package aligned.

The Operating Architecture Behind the Wave

The competition forming around pembrolizumab is revealing more than a race among individual biosimilar candidates. It is also showing how companies are assembling the organizations needed to move those products toward commercial markets.

Cipla–Qilu offers one clear model: concentrate development and technical execution with one partner and U.S. commercialization with another. Formycon shows how one developer can work with different commercialization partners across regions, while Alvotech and Dr. Reddy’s demonstrate a structure in which development and manufacturing are shared.

As pembrolizumab moves toward potential biosimilar competition, those structures may prove as instructive as the candidates themselves. The company visible in the commercial market may represent only the final link in a much more distributed development and supply network.

As these programs move from development toward commercial supply, they will provide an early test of whether globally distributed partnerships can keep technical, regulatory, manufacturing, supply, and commercial responsibilities aligned across organizational boundaries.