Hong Kong Biosimilars Market Analysis, 2024–2034

The Hong Kong Biosimilars Market Analysis Executive Summary

Biosimilar means a biologic product that has been shown to have a high degree of similarity to the existing FDA approved reference product in terms of safety and efficacy. While small molecules have similar structures, biosimilars cannot be identical to the reference product because of the inherent complexity of biologic products. Therefore, the development processes for generics are not applicable to biosimilar products.

To the 3 curative biologics of Avastin (bevacizumab), Herceptin(trastuzumab) and Rituxan(rituximab), biosimilars have performed very well in the last 3 years. They will have increased competition from more numbers of biosimilars expected to enter the market from other manufacturers in the near future. The global biosimilar market is on the rise as patents for big-brand biologics expire, and patients find more affordable treatment options. The FDA and EMA approval systems remain fundamental in monitoring the safety and effectiveness of biosimilars, as well as in managing market access. There are several barriers such as regulatory issues, high production cost, and lack of long-term data, but there are also considerable opportunities especially with new wave of innovative biosimilars. Whereas today North America and Europe are leading in biosimilars, Asia, Latin America, and the Middle East will witness biosimilars growth due to the increasing healthcare costs and prevalence of chronic diseases. All in all, the market will continue to expand attributed to the changes in regulations and expiration of key biologic patents.

Hong Kong Biosimilars Market Dynamics

Market Growth Drivers

The biosimilars market is primarily driven by the expiration of patents for major biologic drugs, which had global sales of $144 billion in 2020. As patents lapse, biosimilars offer a more affordable option for long-term treatments for diseases like cancer and diabetes. Regulatory bodies in key markets, such as the US and Europe, have streamlined the approval process, with over 60 biosimilars approved by the EMA and over 30 by the FDA since 2015. This has lowered entry barriers for new manufacturers. While the US and Europe currently lead the market, increasing use of biosimilars is expected in Asia, Latin America, and the Middle East due to rising healthcare costs and chronic disease prevalence. The upcoming expiration of key biologic patents presents a significant opportunity for the biosimilars market to enhance healthcare access while managing costs effectively.

Opportunity

The market has a broad and growing pipeline with biosimilars available for various therapeutic areas including oncology and autoimmune diseases. Biosimilars in particular have enhanced competition which makes it easier for patients to afford their essential drugs. However, there is a ‘biosimilar gap’ where there are some specific soon-to-expire biologics, which currently do not have any biosimilar, which is a great opportunity for manufacturers. The sector is expected to experience new product approvals and subsequent market launches, specifically targeting the development of the second generation biosimilars that are safer, more efficacious, and convenient for patients. Moreover, the concepts of sustainable manufacturing and manufacturing of medicines that are tailored to individual patients will play a crucial role in the further development of biosimilars.

Market Restraints

One of the primary concerns for biosimilar is the fact that there are different rules regarding the interchangeability of biosimilars with the reference product, which causes worry from physicians and patients, particularly for those on the reference biologic. Other challenges include: inconsistent markets and high costs of production which increases the risks and barriers to entry. Biologics are costly but so are Biobetters which themselves offer enhanced delivery or fewer side effects than the original biologics. Comparatively, biosimilars have scarce long-term safety and efficacy data, as opposed to conventional products, and patients reduce their willingness to switch stable patients, which adds to the complexity. One of the significant strategies for increasing biosimilars use is to gain the trust of physicians regarding these products.

Competitive Landscape for Biosimilars Market in Hong Kong

Key Players

• Novartis
• Pfizer
• Catalent
• Amgen
• Biogen
• PPatheon
• SShanghai Henlius Biotech
• Viatris
• Celltrion

• Recent Developments:

Pyzchiva (ustekinumab-ttwe), a biosimilar to Stelara developed by Sandoz and Samsung Bioepis, was FDA-approved in July 2024 for various conditions including plaque psoriasis and psoriatic arthritis. Sandoz plans to launch it in the US in February 2025, following a settlement with Johnson & Johnson.

Q4 2025, three new biosimilars were approved in the US -

• Avzivi for Avastin (bevacizumab) biosimilar

• Tofidence for Actemra (tocilizumab) biosimilar

• Wezlana for Stelara (ustekinumab) biosimilar

Mergers and Acquisitions

January 2024, Sandoz, a generic and biosimilar medicines company, signed an agreement to acquire the U.S. biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc.

November 2022, Biocon Biologics has completed the multi-billion-dollar acquisition of the global biosimilars business of its partner Viatris Inc.

Healthcare Policies and Regulatory Landscape for Biosimilars Market in Hong Kong

Policy changes and Reimbursement scenario

Regulations play a vital role in the biosimilars development which differ in different regions of the world. Therefore, the reauthorization of Biosimilars User Fee Amendment III (BsUFA III) was done with the intention of further cutting on these processes hence promoting access to biosimilars. Studies on PBM behaviour show that drugs with larger rebates can discourage the utilization of biosimilars, including cost-sharing for patients and market entry. Policy makers at CMS are urged to change payment policies to help biosimilars, regarding concerns like “rebate walls” and decreasing ASPs. Out of pocket expenses are often still elevated for biosimilars and insurance coverage impacts the reason for the shift from the originator product.