Biosimilars are highly similar to biologics and are considered as a cheaper alternative. Approval and launch of biosimilars is expected to increase patient access and potentially reduce the cost of important biological drug therapies. Major regulatory bodies are focused on approving use of biosimilars for various diseases. In 2019, the U.S. Food and Drug Association approved 10 biosimilars. Avsola (infliximab-axxq) was the most recent biosimilar approved by the FDA for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis.
Increasing use of specialty drugs has led to high healthcare expenditure in the U.S. according to The Centers for Medicare & Medicaid Services, the U.S. health spending is projected to reach nearly US$ 6.0 trillion by 2027. Therefore, the U.S. is focused on improving the efficiency of the biosimilar and boost biosimilar competition in the marketplace. In this regards, the government introduced the Biosimilars Action Plan in July 2018. Europe exceeds the number of biosimilar approval compared to the U.S. Early adoption of biosimilars can be attributed to the high biologic costs. In January 2019, Fresenius Kabi received approval for adalimumab biosimilars Idacio and Kromeya from European Medicines Agency (EMA)’s The Committee for Medicinal Products for Human Use. However, the launch of adalimumab biosimilar in the US is delayed until 2023. As of January 2020, the EMA has 14 biosimilar applications under review.
Biosimilar approvals in the U.S
The low number of biosimilar approvals in the U.S. can be attributed to issues such as exclusivity (patenting) and commercialization and long duration of production and approval. However, the U.S. government is keen on taking steps to address the hurdles. In May 2019, the U.S. FDA released industry guidance on the ‘Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations’. Moreover, high cost of biological drugs in the U.S. is also expected to shift patient preference to biosimilar drugs. According to the Association for Accessible Medicines, the launch of new biosimilars is expected to save US$ 250 billion in healthcare cost during 2016-2025.
The patent protection of several biologics is expected to expire in the near future. This is expected to offer lucrative growth opportunities for biosimilar manufacturers. Boehringer Ingelheim’s Atrovent HFA (ipratropium hfa), used for the treatment of chronic obstructive pulmonary disease, is expected to face patent expiration in May 2020 and AstraZeneca’s Bydureon (exenatide), used for the treatment of type 2 diabetes, in October 2020. Such scenario is expected to lead to loss in revenue of biologics. In July 2019, AbbVie Inc. reported a revenue loss of 6.1%. for Humira. Another biologics producer, Amgen Inc. is suffering a major setback in the form of Kyprolis, a blood cancer drug, added to its portfolio after the acquisition of Onyx Pharmaceuticals. The drug, after demonstrating no better efficacy compared to other competitive drugs, is now used a second-line treatment option.
The U.S market is also witnessing several law suits related to biosimilars. In November 2019, Coherus BioSciences dropped a lawsuit against Amgen Inc. in which the former claimed Amgen’s biosimilar of AbbVie’s blockbuster arthritis drug Humira infringes four patents for its own biosimilar version. In September 2018, Amgen Inc. filed a lawsuit against Novartis for patent infringement on Enbrel (etanercept).
Several pharmaceutical companies, including Amgen Inc., have shifted their focus on developing their own biosimilar products. In December 2019, Amgen Inc. and Allergan plc. submitted a Biologics License Application (BLA) to the U.S. FDA for ABP 798, a biosimilar candidate to Rituxan (rituximab). In January 2020, Pfizer, Inc. launched three new biosimilars, ZIRABEV (bevacizumab-bvzr) indicated for the treatment of recurrent glioblastoma in adults, RUXIENCE (rituximab-pvvr) for blood cancers and inflammatory conditions, and TRAZIMERA (trastuzumab-qyyp) indicated for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer, in the U.S.
Increasing development and adoption of biosimilars is expected to promote competition among manufacturers to lower prices. This in turn is expected to increase the accessibility of various therapies. However, the impact of biosimilar drugs on biologics might be two sided. The influence may rely on the extent of the reduced price and the impact of this price reduction on insurers, providers, and patients in terms of volume. Biologic manufacturers are also focused on R&D of next-generation biologics to stay ahead of the competition from biosimilar drugs. However, the adoption of biosimilar drugs is expected to increase when regulatory bodies worldwide determine biosimilars to be interchangeable with the reference biologic.
About Phase XS: Above article is a combined efforts of PhaseXS and CMI team. Phase XS is a unique analytical platform, which helps you to plan your strategy for biosimilar and biologics development. It is a proprietary tool of Coherent Market Insights (CMI) that aims to provide meticulous details of clinical trials (Phase 3 and Phase 4) conducted in the U.S. along with the analytical insights from the team of CMI consultants and verified by industry experts.
Author Bio: Mr. Nirav Gokani is a strategic consultant and working as a Digital Marketing Manager at Coherent Market Insights.