Biogen and Samsung Expand Biosimilars Collaboration with Focus on Ophthalmology

Biogen Announces Expanded Collaboration with South Korean Biopharmaceutical Company Samsung Bioepis, Securing Rights to Ranibizumab (Brand Name Lucentis) and Aflibercept (Brand Name Eylea) Biosimilars (Known as SB11 and SB15, Respectively) in Key Markets Including Europe, the United States, and Japan for an Upfront Payment of $100 Million and Milestone Payments of $210 Million. Additionally, Biogen Will Acquire Rights to Three TNF Inhibitors from the Partnership in the Chinese Market. The Joint Venture Samsung Bioepis Will Be Responsible for the Clinical Development of These Two Drugs.

Samsung Bioepis is a joint venture established by Biogen and Samsung Biologics in 2011, with respective capital contributions of $45 million and $255 million, under which Biogen held a 15% equity stake. Last year, Biogen injected an additional $700 million to increase its ownership to 49.9%, clearly reflecting heightened expectations for biosimilars. The two companies have developed biosimilars for several blockbuster drugs, which generated $550 million in sales for Biogen last year, representing a 43% year-over-year increase. In addition to the robust growth of the existing pipeline, Biogen’s $800 million acquisition earlier this year of Nightstar, a gene-editing company focused on ocular diseases, to enter the ophthalmology sector is also a factor driving the expansion of their partnership today.

In 2019, the global market for retinal disease therapeutics was valued at $11 billion, with anti-VEGF antibodies accounting for 90% of this market. Although there are various types of retinal diseases, age-related macular degeneration (AMD) and diabetic macular edema (DME) are the most prevalent, affecting 196 million and 146 million patients worldwide, respectively. Age and diabetes are the primary risk factors for retinal diseases; as the population ages and the prevalence of diabetes continues to rise, the incidence of AMD and DME is expected to keep growing for some time. However, the development of new drugs for retinal diseases has been slow due to technical challenges such as complex pharmacokinetic/pharmacodynamic (PK/PD) relationships and the difficulty of administering drugs to the fundus. Fovista, an oligonucleotide aptamer targeting PDGF developed by Ophthotech, represents a rare novel mechanism of action, but it has failed in several Phase III clinical trials. Existing drugs and minor improvements to these agents will continue to dominate this large market for the long term. Since these therapies require intravitreal injection, injection frequency is a critical factor. Currently, Novartis and Regeneron both have next-generation long-acting anti-VEGF products in late-stage clinical development.

Unlike small-molecule drugs, biologics present significantly greater challenges for biosimilar development due to their complex structures, post-translational modifications of proteins, and impurities that are highly dependent on manufacturing processes. Out of an abundance of caution, regulatory authorities have imposed stringent requirements on biosimilars, thereby extending product development timelines and increasing costs. Current estimates suggest that developing a single biosimilar costs between $100 million and $200 million and takes 7–8 years. In addition to this complex and lengthy process, market access is further hindered by the intricate patent networks surrounding originator products and physicians’ unfamiliarity with biosimilars. These factors necessitate that biosimilar manufacturers achieve a certain scale to ensure sustainable development, given the high risks associated with individual products. Although the U.S. has approved 24 biosimilars, only 10 have entered the market, and even fewer are truly profitable. It is estimated that small-molecule generics have saved U.S. patients $1 trillion in healthcare expenditures over the past decade, whereas biosimilars have contributed limited savings to date.

Biologics account for the majority of blockbuster drugs, so the potential for biosimilars remains enormous; it is estimated that they will save the US healthcare system $50 billion by 2026. However, to achieve this goal, biosimilar manufacturers still have much work to do, primarily in persuading the FDA to reduce unnecessary clinical trials and gaining physicians’ recognition of the value of these products. The FDA has publicly stated its willingness to contribute to lowering drug prices, so reasonable proposals are likely to be readily accepted. Last year, the FDA issued a guidance on biosimilars, but after a professor challenged several requirements as unreasonable, the FDA unprecedentedly withdrew the guidance quickly. The FDA is expected to streamline clinical requirements in the coming years. The entry of major pharmaceutical companies such as Roche and Amgen into the biosimilar market will also accelerate the development of this sector, at least ensuring a more robust market establishment for new patients without interchangeability issues. Metabolic turnover is a necessary condition for the healthy growth of new drug innovation; “evergreen” products are not conducive to innovation in new drugs.