Description
Biopharmaceuticals are synthetic or recombinant versions of natural biologic substances, including proteins such as enzymes or antibodies, and nucleic acids such as DNA or RNA. Generic products are non-patented chemical and therapeutic equivalents of brand name drugs. However, biosimilars are not generic biologics because there can be no generic form of biologics due to the complex process of creating biologics. Biosimilar Market Trends 2019 is designed to provide a snapshot of issues and trends that are affecting the biosimilar market today, along with the various strategies being used by both innovator companies and generic companies in the developing world of biosimilars. Market data on the global opportunity for biosimilars provided include:
- Global Biosimilar Market Opportunity, 2019-2024 ($ Millions)
- Biosimilar Competitor Analysis, Estimated 2019 (% Global Market Share)
- European Union Biosimilar Market, 2019-2024 ($ millions)
- United States Biosimilar Market, 2019-2024 ($ millions)
- Global Biosimilar Market Opportunity by Region, 2019-2024 ($ Millions) (European Union, United States, Rest of World, Global Biosimilar Market)
- Rest of World Biosimilar Market, 2019-2024 ($ millions)
- Global Biosimilar Market Growth by Region, 2019-2024 (%) (European Union, United States, Rest of World)
The issues and trends surrounding the prescription biosimilars pharmaceutical market are many but, as the pharmaceutical industry has experienced in the past, the generics industry is tough, resilient and determined. The generics industry has managed to overcome obstacles and prevail. It is expected that with due diligence, the generics industry will not only break into the biotechnology market but create formidable competition for brand biotech companies and reap substantial profits. However, the report does note several issues that will first need to be addressed, including:
- Legislative Issues and Guidelines
- Interchangeability
- Patent and Patent Dance Issues
- Provider Education
- Switching Concerns
- Innovator Strategies and Challenges
- Reimbursement Issues
- Biosimilar Naming and Labeling
Kalorama has identified the biopharmaceuticals that have lost patent protection and are the first products to reach the market. Some of these products are relatively simple in structure (by biotech complexity) such as the insulins and human growth hormones, while others are extremely difficult to process. Kalorama also has identified biopharmaceuticals for future expired biologic patents. Biosimilar market data provided include:
- Select Marketed Biologics with Expired Patents
- Select Marketed Biologics with Active Patents
The development of the global market for biosimilars presents an opportunity for cost savings and improved health outcomes. Despite the benefits, the market has been slow to develop and is only a fraction of its potential. The path to making biosimilars as common as traditional generic drugs has historically been a slow and agonizing process for all involved; but there are some major industry changes in the past couple years that have extended the market, improved regulatory processes and brought more biological options to health professionals and patients around the world. The report provides the following information on the current state of biosimilar development by regional market:
- Biosimilar Approval by Product and Region (Biologic, Product/Innovator, United States, European Union, Japan, Canada, China, South Korea, Australia)
- Biosimilar Approvals by Region (United States, European Union, Japan, Canada, China, South Korea, Australia)
- Biosimilars Approved in EU (Biosimilar Name, Manufacturer, Reference Drug, Approval Date)
- Biosimilar Competitor Activity: European Union (Number of Approvals by Biologic)
- Biosimilars Approved in United States (Biosimilar Name, Manufacturer, Reference Drug, Approval Date)
- Biosimilar Competitor Activity: United States (Number of Approvals by Biologic)
- Biosimilars Approved in Japan (Biosimilar Name, Manufacturer, Reference Drug, Approval Date)
- Biosimilar Competitor Activity: Japan (Number of Approvals by Biologic)
- Selected Biosimilars Approved in India (Biosimilar Name, Manufacturer, Reference Drug, Approval Date)
- Biosimilar Competitor Activity: China (Number of Approvals by Biologic)
- Biosimilars Approved in South Korea (Biosimilar Name, Manufacturer, Reference Drug, Approval Date)
- Biosimilar Competitor Activity: South Korea (Number of Approvals by Biologic)
- Biosimilars Approved in Australia (Biosimilar Name, Manufacturer, Reference Drug, Approval Date)
- Biosimilar Competitor Activity: Australia (Number of Approvals by Biologic)
Biosimilar Market Trends 2019 examines as well legislative and patent issues. Global biosimilars are continuing to grow worldwide with emerging regions playing a larger role. As demonstrated by analysis of various countries, many emerging markets are establishing biosimilar regulatory pathways, providing increasing opportunities for biosimilar development. However, there are still regulatory and operational hurdles to address. Uniform clinical studies remain an issue and harmonization between country regulations is still concerning. Guidelines in many emerging countries are patterned after European Medicines Agency (EMA) guidelines, which is helping to provide some semblance of comparable harmonization in requirements. Issues discussed in the report include:
- EU Guidelines
- US Guidelines
- Interchangeability
- Patent and Patent Dance Issues
For the purposes of this study, Kalorama has focused on the market for products which have lost patent protection in key markets. Projections were made based on the progress that is occurring within the generic arena in terms of capabilities, capital, interest, and development of biopharmaceuticals. The information and analysis presented in this report are based on an extensive survey of senior management in the biosimilar drug industry. Background information was obtained from a comprehensive search of published literature and reports obtained from various government, business, medical trade, and international journals. Key information from published literature was used to conduct interviews with industry executives and product managers to validate and obtain expert opinion on current and future trends in the biosimilar industry. Interviews were also used to confirm and/or adjust market size, as well as in formulating market projections.
