Celltrion Targets Blockbuster Patent Cliff With Next Wave Biosimilars

[NA Eun-kyung, Edaily Reporter] Celltrion is accelerating development of next-wave biosimilars aimed at global blockbuster drugs positioning itself for a new growth trajectory as a sweeping round of patent expirations reshapes the market. Building on 11 products already commercialized, the company plans to expand its lineup to 18 products by 2030. With the biosimilar market set to widen sharply as patents lapse analysts expect Celltrion’s early pipeline buildout to further strengthen its global footprint.

Celltrion said Thursday it has seven candidates that have either entered clinical development or are preparing to file an investigational new drug application.

Key disclosed programs include biosimilars to Ocrevus(CT-P53), Cosentyx(CT-P55) and Taltz(CT-P52) in autoimmune diseases, as well as cancer therapies Keytruda(CT-P51) and Darzalex(CT-P44). Most of the programs are in global Phase 3 trials nearing the final stage of development.

If Celltrion launches these products sequentially, its addressable market is expected to expand sharply. The company currently targets a market worth about 85 trillion won, but that figure could more than triple to 274 trillion won by 2030 if the planned follow on biosimilars are rolled out without disruption. Over the longer term Celltrion aims to build a portfolio of 41 products by 2038 to compete in a biologics market estimated at roughly 408 trillion won.

Celltrion’s Global Biotechnology Research Center. (Source: Celltrion)

◇A blockbuster wave of expirations opens a market worth hundreds of trillions

The global biologics market is set for a large scale patent cliff over the next decade. The Korea Bio Association projects that patents for about 200 biologic drugs will expire by 2030. Of those roughly 70 are blockbusters with annual sales exceeding $1 billion.

For biosimilar developers, that translates into a vast new market opportunity. Celltrion has been building its pipeline early to capture demand created by the patent cliff. While reinforcing its core franchises in autoimmune disease and oncology the company is also seeking to broaden into new therapeutic areas such as ophthalmology and bone disorders.

Industry officials point to Celltrion’s end to end capabilities across the biosimilar value chain as a key advantage. “Celltrion is an industry leader that entered the field in 2002, when biosimilars were still an unfamiliar concept”

said an executive at a biosimilar company. “It has built a local direct-sales system in addition to development and manufacturing and it is prepared for legal disputes through its patent lawyers.”

The official added that Celltrion has infrastructure spanning the full A-to-Z of the biosimilar business and competitiveness across quality, development, production and sales.

Another industry source said Celltrion has accumulated know-how and specialized talent since launching its biosimilar business in the early 2000s, calling that experience an important edge in global competition.



◇SC formulation shifts and bundling strategy strengthen differentiation

Celltrion is also focusing on formulation based differentiation rather than simply expanding the number of products.

A key example is its subcutaneous (SC) formulation technology. After becoming the first in the world to develop an infliximab SC formulation, marketed in the United States as Zymfentra, Celltrion has recently completed clinical work for Herceptin biosimilar Herzuma SC (CT-P6 SC) using hyaluronidase. The product is also seen as a leading candidate to become the world’s first hyaluronidase biosimilar.

Celltrion said it has secured in-house capabilities spanning development, regulatory approval, mass production and global supply for SC formulations. The company plans to apply SC technology across multiple follow on programs aiming to improve dosing convenience as it competes in global markets.

The company’s bundling strategy, supported by a broad portfolio, is also cited as a strength. Bundling refers to selling two or more products together, enabling large volume supply while encouraging prescribing across multiple in house products. The approach can strengthen bidding competitiveness and improve salesforce efficiency.

A Celltrion researcher works on developing biosimilar formulations. (Source: Celltrion)

◇Biosimilars enter a 10 year golden era

Global market watchers are also increasingly bullish on the biosimilar industry’s growth outlook. Clarivate Life Sciences & Healthcare, in its recent report “Decoding Biosimilars: How to Stay Ahead in This Rapidly Evolving Market” forecast the next decade will be the industry’s key growth window.

According to the report, the biosimilar market across the Group of Seven countries is projected to expand from about $16 billion in 2024 to more than $70 billion in 2033, or over 102 trillion won. That implies a compound annual growth rate of about 18%.

Clarivate said biosimilars are becoming a central strategy for health systems by cutting costs and expanding patient access, and that future competitiveness will hinge not only on price but also on regulatory execution, clinical data and depth of market understanding.

Against that backdrop, industry sources expect Celltrion’s strengths to stand out further. “In biosimilars, it is critical to respond quickly to regulatory changes and closely analyze local market dynamics” said a biosimilar expert. “Celltrion already has both global commercial infrastructure and development capabilities, which gives it significant room to grow.”

A Celltrion official said the company is entering a new growth phase as development of biosimilars to global blockbuster drugs nears completion, adding that it plans to leap into the ranks of global big pharma by expanding its portfolio to 18 products by 2030 and 41 over the long term backed by SC formulation technology and a direct-sales model.