Five biosimilar companies you should know about

As big pharma faces a looming patent cliff that could put more than $200 billion in annual revenue at risk through 2030, it opens up a major opportunity for biosimilar developers. This is because, unlike the patent cliff at the start of the last decade, which primarily involved chemical pills that previously dominated the market for big pharma, this one includes a fair number of biologics, making the transition to biosimilars highly significant. In this article, we take a look at five biosimilar companies hoping to capitalize on this situation. 

Alvotech 

• Two approved drugs: Selarsdi and Simlandi; biosimilars to J&J’s Stelara and AbbVie’s Humira
• Approvals came thanks to partnership with Teva Pharmaceutical, formed in 2020 
• Partnership with Advanz Pharma recently resulted in EMA acceptance of Simponi biosimilar

Focused solely on the development and manufacture of biosimilar medicines for patients worldwide, Alvotech already has two approved biosimilars that are marketed for use in multiple countries, including the U.S., Canada, Japan, and several European countries, among others. Additionally, the company currently has a pipeline of nine biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. 

Alvotech’s two approved drugs are called Selarsdi and Simlandi, which are biosimilars to Johnson & Johnson (J&J)’s Stelara and AbbVie’s Humira, respectively. First approved by the U.S. Food and Drug Administration (FDA) in April 2024, Selarsdi is intended for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older. And, in October, the FDA decided to expand Selarsdi’s label to include further indications that its reference product Stelara is used to treat. Meanwhile, Simlandi, which was approved in February 2024, is for the treatment of a long list of diseases: adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa, and adult uveitis.

These two approvals came off the back of Alvotech’s successful partnership with Teva Pharmaceutical, which was formed in 2020 with the aim of commercializing five biosimilar product candidates in the U.S. Alvotech has also formed a partnership with Advanz Pharma, which recently resulted in the European Medicines Agency (EMA) confirming its acceptance of the two companies’ marketing authorization application for a biosimilar to J&J’s Simponi, a biologic used to treat several chronic inflammatory diseases. The approval process for this is anticipated to be completed in the fourth quarter of 2025.

Biocon Biologics

• Eight commercialized biosimilar products 
• Most recent FDA approval: Yesintek; biosimilar to J&J’s Stelara 
• Acquired Viatris in 2022 after long-term partnership; and partnered with Sandoz in 2018

A subsidiary of Indian biopharma company Biocon, Biocon Biologics is advancing a range of biosimilars that offer affordable solutions to biologic medicines. The company currently has a broad pipeline of 20 biosimilar molecules spanning insulins, monoclonal antibodies, and conjugated recombinant proteins, eight of which are already commercialized products. 

And, just this week, the company announced that it had received FDA approval for Yesintek, its biosimilar to J&J’s Stelara. The drug is a monoclonal antibody that prevents abnormal regulation of interleukin IL-12 and IL-23-associated immune diseases and is intended for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The approval follows a settlement and licensing agreement with J&J that allows Biocon Biologics to commercialize Yesintek in the U.S. no later than 22 February 2025, following FDA approval.

The approval of Yesintek is another step forward for Biocon Biologics in pushing into the U.S. biosimilar market, which it has had a presence in for a few years now, thanks to its long-term partnership with Mylan – now called Viatris after the combination of Mylan and Upjohn. Together, Biocon Biologics and Viatris launched Fulphila, the first biosimilar to Amgen’s Neulasta, and Ogivri, the first biosimilar rival to Genentech’s blockbuster Herceptin. Then, in 2022, Biocon Biologics acquired Viatris, providing the biosimilar company with direct commercial capabilities and supporting infrastructure in the advanced markets and several emerging markets, bringing it closer to patients, customers, and payors.

Biocon Biosimilars has also formed several other partnerships, including with Novartis’ generics and biosimilars spin off Sandoz, with the intention of developing, manufacturing, and commercializing multiple biosimilars in immunology and oncology for patients worldwide.

Celltrion

• Infliximab biosimilar: world’s first monoclonal antibody biosimilar approved by EMA
• Most recent approval: SteQeyma; biosimilar to Stelara
• Formed biosimilar commercial partnership with Teva Pharmaceutical

South Korean-based company Celltrion specializes in researching, developing, manufacturing, marketing, and selling biosimilars. The company currently has several biosimilar products approved by the EMA and FDA, including Zymfentra, which became the first and only FDA-approved subcutaneous formulation of infliximab (first developed by J&J under the brand name Remicade) for the maintenance treatment of adult patients with moderately to severely active ulcerative colitis and Crohn’s disease when it was given the green light last year. It works by blocking the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body.

Zymfentra is a version of Celltrion’s infliximab biosimilar, which was the world’s first monoclonal antibody biosimilar to be approved by the EMA, launching in 12 major European countries in 2015. The FDA also approved the biosimilar in 2016 under the trade name Inflectra. The drug is now indicated for the treatment of several autoimmune diseases, including adult and pediatric Crohn’s disease, adult and pediatric ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, and psoriatic arthritis.

Most recently, the company also had its Stelara biosimilar, called SteQeyma, approved by the European Commission (EC) for the treatment of multiple chronic inflammatory diseases. This makes the drug Celltrion’s seventh biosimilar approved for use in the European Union (EU). 

Celltrion has formed numerous collaborations over the years, including with Pfizer to market Inflectra in the U.S. Although Pfizer also previously held the rights to two of Celltrion’s drugs, CT-P6 and CT-P10 – biosimilars to Roche’s cancer drugs Herceptin and cancer drug Rituxan, respectively – it handed them back after acquiring Hospira for $17 billion in 2015, as Hospira already had biosimilars for those products in its pipeline. Since then, Celltrion has formed an exclusive partnership with Teva Pharmaceutical that now allows Teva to market CT-P6 and CT-P10.

Formycon 

• Three FDA approved biosimilars: FYB201, a biosimilar to Lucentis; FYB203, a biosimilar to Eyelea; FYB202, a biosimilar to Stelara
• Long-term strategic partnership with Athos: agreement to merge biosimilar development activities
• Global license agreement with Fresenius Kabi for commercialization of FYB202

Formycon is focused on developing biosimilars primarily for ophthalmology and immunology indications, as well as other key chronic diseases. The company currently has three biosimilars on the market, including FYB201, a biosimilar to Genentech’s Lucentis (ranibizumab), which was approved by both the FDA and EC in 2022. Ranibizumab is used in the treatment of various eye diseases in adults that cause damage to the retina and lead to impaired vision or even blindness. In these diseases, a protein called vascular endothelial growth factor (VEGF) causes excessive blood vessels to form within the retina, resulting in a progressive loss of central vision. Ranibizumab combats this by inhibiting certain growth factors involved in the formation of new blood vessels.

Meanwhile, Formycon’s most recent approvals came in the summer of this year. In July 2024, the FDA approved FYB203, a biosimilar to Regeneron’s Eyelea (aflibercept), which, like ranibizumab, is used in the treatment of neovascular age-related macular degeneration (nAMD), along with several other eye diseases. It works by binding to VEGF-A, as well as to placental growth factor (PLGF), suppressing the formation of blood vessels in the retina. Then, in September 2024, the FDA also gave the green light to FYB202, a biosimilar to Stelara. 

In March 2022, the biosimilar company formed a long-term strategic partnership with Athos, as the two companies agreed to merge their biosimilar development activities. This involved Formycon acquiring 100% of the rights to FYB202, as well as the 50% stake of Athos in FYB201 and the operational development unit Bioeq. Furthermore, Formycon also announced a global license agreement with Fresenius Kabi in February 2023 for FYB202, meaning that Fresenius Kabi will commercialize FYB202 in key global markets. In accordance with a patent settlement between Fresenius Kabi, Formycon, and J&J, Fresenius Kabi has the right to market the biosimilar in the U.S. no later than April 2025.

Samsung Bioepis 

• Nine biosimilar approvals, including three FDA approvals in 2024
• Five biosimilars developed with commercialization rights held by Biogen
• Ongoing partnership with Merck for biosimilar candidates

Samsung Bioepis is advancing a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Plus, the company already has nine approved products to its name in various markets.

This year alone, the biosimilar company has managed to bag FDA approvals for three of its products: Pyzchiva, a biosimilar to Stelara; Epysqli, a biosimilar to Alexion’s Soliris; and Opuviz, a biosimilar to Eyelea. When the FDA approved Opuviz in May 2024 along with Biocon Biologics’ Yesafili, the two drugs became the first interchangeable biosimilars to Eylea. 

Opuviz is the fifth biosimilar in Samsung Bioepis’ portfolio developed with commercialization rights held by Biogen. The partnership first commenced in 2013, when the two companies announced an agreement to market anti-TNF biosimilar candidates in Europe, including biosimilars for widely used therapies to treat conditions such as rheumatoid arthritis and Crohn’s disease. Then, in 2019, they entered into another commercialization agreement, this time for two ophthalmology biosimilar candidates, Byooviz (ranibizumab) and Opuviz (aflibercept), in the U.S., Canada, Europe, and certain other markets.

Samsung Bioepis has also formed a partnership with Merck, which includes a 2013 agreement to develop and commercialize multiple pre-specified and undisclosed biosimilar candidates, and a 2014 expansion deal to develop, manufacture, and commercialize MK-1293, an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes.

Patent cliff set to open market for biosimilars 

A “patent cliff” refers to when a company’s patents for one or more of its best-selling branded products expire. Ultimately, this opens the door for competitors to sell so-called copycats of those drugs, usually at a lower price. Typically, the consequences of a patent cliff are that revenues for big pharma companies will fall, while costs for patients will drop, meaning they can access more affordable options.

As mentioned previously, because many of the biggest drugs facing patent expirations are biologics, including Merck’s Keytruda, J&J’s Stelara, and Bristol Myers Squibb (BMS)’s Opdivo, it presents the perfect opportunity for biosimilar companies to develop their own versions of these drugs. As an example, almost all of the companies in this article have already had their version of Stelara approved for patient use. 

The upcoming patent cliff means that nearly 200 drugs are going off-patent in the near future, including at least 69 blockbusters that generate more than $1 billion in annual sales, meaning it is going to affect almost every big pharma company in some way or another. But it’s also worth noting that, despite the upcoming patent cliff, big pharma has an enormous capacity to respond as “conditions for M&A are favorable,” according to a research note from Morgan Stanley, as reported by Fierce Pharma. 

Indeed, certain drugmakers appear well prepared to offset losses, as they are already trying to build their drug pipelines up and form acquisitions or partnerships with other companies. For example, Amgen, which, according to Fierce Pharma, has the most revenue at risk at 67%, has already taken a major step in addressing the patent cliff with its $27.8 billion acquisition of Horizon, which brought with it potential blockbusters in Tepezza for thyroid eye disease, Krystexxa for gout, and Uplizna for a rare neurologic disorder.

Still, the biosimilar market is expected to grow in the coming years. According to a new market research report, the global biosimilar market size was calculated at $34.66 billion in 2024 and is expected to reach around $150.26 billion by 2033, expanding at a compound annual growth rate (CAGR) of 17.7% in the forecast period. North America dominated the market with the largest revenue share of 41.0% in 2023. 

This just goes to show that the biosimilar market in the U.S. in particular is growing quickly, as it has recently been boosted by FDA regulations and rising demand for lower-cost treatments. And, the companies named in this article will certainly be hoping to capitalize on this.