by Current Biosimilar Landscape
The biosimilar drug market has seen significant growth over the past decade since the introduction of the first biosimilar. As many blockbuster biologics are expected to go off-patent in the coming years, the biosimilar development pipeline is booming with follow-on versions of these biologics. According to a recent report, over 300 biosimilar drug products are currently in various stages of clinical development or are awaiting regulatory approval.
The approved Biosimilar Pipeline Analysis has been dominated by three therapeutic classes – monoclonal antibodies, human growth hormone, and granulocyte colony-stimulating factor. Biosimilars referencing etanercept, infliximab, insulin glargine, and filgrastim have captured a major share of the global biosimilar sales. While Europe has led the adoption of biosimilars, with a robust uptake seen across many countries, the U.S. market is also emerging as a key region following the recent patent expiries. The increasing acceptance of biosimilars among physicians and patients bodes well for the future growth prospects.
Top 10 Products by Development Status
Let us take a closer look at the top 10 most promising biosimilar candidates currently in the pipeline based on their development status:
1. Adalimumab biosimilar – Many companies have drugs in late-stage trials targeting the autoimmune disease market for Humira, including Samsung Bioepis, Mylan/Fujifilm Kyowa Kirin, Coherus, Boehringer Ingelheim.
2. Bevacizumab biosimilar – Samsung Bioepis, Pfizer, Amgen, Mylan all have bevacizumab biosimilars in Phase III targeting oncology.
3. Trastuzumab biosimilar – Samsung Bioepis, Amgen, Mylan have drugs in late-stage development to compete in the breast cancer market for Herceptin.
4. Rituximab biosimilar – Mylan, Truxima (Celltrion), Pfizer’s RUXIENCE are some of the approved copies of Rituxan already addressing the non-Hodgkin’s lymphoma market.
5. Insulin glargine biosimilar – Most companies like LG Chem, Eli Lilly, Gan & Lee have Phase III assets targeting the soluble insulin segment.
6. Etanercept biosimilar – Samsung Bioepis’ BENEPALI & Erelzi from Sandoz are leading the race in rheumatoid arthritis post Enbrel’s US exclusivity loss.
7. Infliximab biosimilar – Celltrion’s Remsima, Pfizer’s Inflectra already popular biosimilars in IBD/RA space post-Renbrel exclusivity loss.
8. Teriparatide biosimilar – Gedeon Richter leading with Phase III drug for postmenopausal osteoporosis as Forteo loses protection.
9. Ranibizumab biosimilar – Samsung Bioepis, Pfizer, Formycon with Phase III assets targeting wet AMD market of Lucentis.
10. Somatropin (rDNA origin) biosimilars – Many including Liht Bio, Ascendis, GeneScience in Phases 2-3 targeting pediatric/adult growth hormone deficiency.
Diversified Therapeutic Focus
While Biosimilar Pipeline Analysis were initially concentrated in easier to develop classes like monoclonal antibodies and recombinant proteins, the pipeline shows growing diversity in targeted indications. Oncology, as the largest biologics market, naturally has the highest number of biosimilar candidates in development. Autoimmune conditions like rheumatoid arthritis also attract significant biosimilar interest given the large patient populations dependent on biologic drugs.
Other therapeutic areas witnessing increased biosimilar pipeline analysis activity include ophthalmology, endocrinology, hematology and dermatology. A growing number of programs are focused on the developing world where cost of treatment is a critical factor. Several biosimilar developers are targeting tropical diseases with biologic reference products from the likes of Roche, GSK and Sanofi. The pipeline also reflects newer modalities gaining attention from biosimilar players, such as fusion proteins, peptides and viral vectors.
Regulatory Considerations
The approval timelines for biosimilars vary significantly based on the regulatory pathway and requirements in different regions. The European Medicines Agency (EMA) has approved over 80 biosimilars to date, having established a clear and predictable regulatory pathway. Most EMA approved products receive international approvals in other regions, including Canada and developing markets, enhancing their commercial visibility.
The US FDA has now approved over 30 biosimilars. However, unlike small molecules, mandatory extra-statutory exclusivity periods continue to delay biosimilar competition for many biologics in the US. The recent amendments to the Biologics Price Competition and Innovation Act also allow interchangeability, but none have yet received such designation. Japan has an established but selective pathway, while China is seeing rapid growth supported by an evolving regulatory framework. Regulatory delays and legal disputes remain the key risks for timely market entry even for well-developed biosimilar candidates.
Challenges and Success Factors
While biosimilars promise significant cost savings compared to their reference products, their adoption rate remains dependent on various medical, scientific and economic factors. Demonstrating efficacy, safety and immunogenicity comparable to innovator products is critical for gaining physician confidence. Access to clinical trial samples of the reference product is also vital but can be restricted.
Other challenges include demonstrating structural/functional similarity for complex molecules, ability to consistently manufacture at commercial scale, and ability to differentiate from biosimilar competitors and reference products through their value proposition alone. Winning early tenders and contracts with health systems is key to gaining real-world experience and cementing market share for newly launched biosimilar pipeline analysis. Success ultimately depends on a balanced and forward-looking policy framework to maximize the benefits offered by biosimilars.
*Note:
1.Source: Coherent Market Insights, Public sources, Desk research
2.We have leveraged AI tools to mine information and compile it
About Author - Vaagisha Singh
Vaagisha brings over three years of expertise as a content editor in the market research domain. Originally a creative writer, she discovered her passion for editing, combining her flair for writing with a meticulous eye for detail. Her ability to craft and refine compelling content makes her an invaluable asset in delivering polished and engaging write-ups. LinkedIn
