Biosimilar
What are biosimilars?
Biosimilars are laboratory-generated clones of high-priced Biologics. Having the same structure as their parent biologics,
biosimilars provide the same pharmaceutical effects at affordable prices, improving access to medical treatments patients need.
Biosimilars are a new paradigm of therapeutic agents that have revolutionized the social economy.
Difficulties in the Development of Biologics
Compared to chemically synthesized pharmaceuticals, biologics display complex crystal structures resulting in a more challenging process for development and production.

Differences in the level of technology required for the development of biologics compared to generic pharmaceuticals are analogous to the technological differences observed between development of a bicycle, automobile and airplane.
History of the Development and Regulation of Biosimilars
The European Medicines Agency (EMA) was the first regulatory body to issue guidelines on biosimilars. On Oct. 30, 2005, the "Guideline on similar biological medicinal products" came into effect in Europe, providing an overarching framework for obtaining approval for a biosimilar in the European Union. This paved the way for the subsequent launch biosimilars in Europe, which leads globally in the number and usage of biosimilars. The World Health Organization (WHO) and countries including Canada and Australia have followed the EMA's lead soon after and adopted similar principles in their guidelines. US FDA developed an overall framework for biosimilars between 2009 and 2012, and issued a final guideline in 2015. In China, CFDA also issued the "Technical Guidelines for Research and Development and Evaluation of Biosimilars (draft)" in 2015, which defined biosimilars as biological products with similar quality, safety and efficacy to registered reference drugs. As regulatory pathways have now developed almost across the world, and many major biological therapeutics (e.g. Humira, Herceptin, MabThera, Remicade, etc.) have started to lose exclusivity, biosimilars are becoming more widely approved and accepted globally.
Benefits of biosimilars
Benefiting from breakthroughs in genetics, molecular biology and biochemistry, biological therapeutics truly revolutionized and transformed the treatment paradigm, patient care, long-term clinical outcomes and public healthcare budget for cancer, autoimmune diseases, and chronic diseases around the world. The global market for biologic therapeutics has exceeded $200 billion in 2016. Currently, among the top ten best-selling drugs worldwide, eight are biologics.

Because of the high technical barriers to the production of biologics and the difficulty in process quality control, the prices of biological therapeutics are more expensive and patient access is lower than that of chemical drugs. Globally, the approval of biosimilar medicines has led to a significant increase in the number of patients who are able to receive biological therapy due to their lower cost. Not only are biosimilars less expensive than originator biologics, they also bring competition to the market, forcing down the cost of these expensive medicines. It is estimated that biosimilars will reduce direct spending on biologic drugs by US$54 billion from 2017 to 2026 in the US1. A published pharmacoeconomic study2 estimated that the introduction of a trastuzumab biosimilar (CT-P6) would provide substantial national budgetary savings ranged from €872 million to €2,635 million in the 28 countries of the European Union, and these savings would allow an additional 52,154 to 134,543 patients to gain access to trastuzumab over a five-year period, therefore improving the public health landscape.

The cost savings with biosimilars also have an impact on treatment regimens and our approach to biological therapy. Biosimilar medicines have potential to provide an appropriate environment in which patients can be treated when necessary without treatment delay.

In summary, biosimilars will provide
Introduction of world-class, high-quality and affordable biosimilars can benefit China and Chinese patients
In 2019, IQVIA and Vcell have jointly completed a pharmacoeconomic study3 to assess the budget impact of Herceptin (trastuzumab) biosimilar (CT-P6) in China. In the study, it was found that the increasing epidemiology of breast cancer and gastric cancer in China has caused heavy disease burden to Chinese patients, and significant economic burden to both the medical insurance fund and patient families, resulting in low patient access. The introduction of a world-class, high quality and affordable biosimilar can provide significant savings in the national medical insurance fund. Such budget savings can be used to treat additional patients and provide insurance coverage for more innovative drugs, thus optimize health care resource allocation. In addition, due to biosimilar's more affordable price, patient access will be significantly improved, and fewer families would suffer from "poverty and fall back to poverty due to illness" (shown in the following two charts).


Production technology is the main technical challenge of biologics manufacturing
The development and production challenge of biosimilars is mainly in the biosynthesis of effective ingredients. Although the structure, function and therapeutic effect of effective ingredients are public information, large scale and high purity production is the key, and the technical challenge is mainly in the production process. The biosynthesis of biological drugs can be divided into two steps: upstream and downstream. Upstream steps usually include cell culture and harvesting, while downstream steps include multi-step purification. Laboratory level small-scale production and commercial large-scale production are different in technology. Large-scale production technology is one of the important technological challenges. The difficulties of large-scale production mainly lie in improving production efficiency and stable quality control. Production of the small molecule chemical drugs is more mature. The production line construction, maintenance costs and variable costs of drug production are relatively low, and there is no major threshold in large scale production. On the contrary, production of biosimilars represents the characteristics of a "high threshold" industry, large-scale and high-purity production is the key to lower drug costs.
Celltrion's large-scale production facility is the 1st cGMP Facility approved by US FDA in Asia
With 190,000L total production capacity, the Celltrion's large-scale production facility is the first Asian cGMP Facility approved by US FDA back in 2007. Recent GMP approvals of the facility were in 2018 by US FDA, EMA and PMDA. Celltrion has successfully launched biosimilar products around the world with rapid market share growth. Available real-world evidence has demonstrated efficacy and safety of the products.
1. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Rand Health Q. 2018;7(4):3 (eCollection 2018 Mar.)
2. D. Suh, S. Lee, and D. Suh, "PCN69 - Budget Impact of Substituting Biosimilar Trastuzumab (CT-P6) in Treating Gastric Cancer and Breast Cancer in 28 European Countries," Value Health, Vol. 21, P. S25, Oct. 2018.
3. Budget Impact Analysis of Trastuzumab Biosimilar CT-P6 on HER2+ Breast Cancer and Gastric Cancer Treatment in China, IQVIA and Vcell, 2019
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