Five Things To Know About The 6.2 Billion-Dollar Biosimilar Business

Rockville, MD /PRNewswire/ - Kalorama Information estimates that the global market for biosimilar products has grown to be worth almost $6.2 billion by the end of the year, according to its new report, Biosimilars: Global Market, Trends and Competitor Analysis. The healthcare market researcher notes that although biosimilars are somewhat like generics, they are not exactly generic biologics due to the complex process of creating biologics. What this means is, competition has arrived for big biopharmaceutical drugs in world markets. And competition is coming to the U.S.

Kalorama's report says a number of companies are jockeying for position. Several players are emerging as either Rest of the World (outside of Europe, Japan, and North America) active participants or working in partnership with Rest of World companies. Until recently, a market did not exist in the United States. Europe has an operating pathway in place and is forging ahead with approvals. However, there are still some limitations to uptake of biosimilars in Europe due to resistance from innovator companies. Kalorama's report notes five factors to watch in assessing the market opportunity for biosimilars:

• Europe Rising: The EU is the first in the world to have defined a policy and legal framework for biosimilars. Absence of such regulation and biosimilars approval process in other countries, in particular in the United States, can lead to a competitive advantage to the EU biosimilars industry. The EU is well ahead of the US in the progression of biosimilars. Since its passage of an established pathway, the EU has been able to approve biosimilar products on the basis of the scientific guidelines and requirements that have been established.
• U.S. Pathway Open: Until recently, biosimilars could not be marketed in the United States because there was no pathway for these products to reach the market as explained in more detail in Chapter 2. Congress did not include biologics within the scope of the Hatch-Waxman ANDA provisions because only a few biotechnology-derived drugs existed when the act was enacted in 1984. Also, the process to derive biotechnology products was so involved that Congress probably did not even consider it as a possibility. However, continuous technological improvements in the ability to produce and test biologically derived drugs and socioeconomic and political changes have provided a regulatory framework permitting biosimilars in the U.S. marketplace starting in 2015.
• Patents: A possible barrier to entry for biosimilars is the complex patent atmosphere. Patents have been part of the complex world of intellectual property. This includes patents, trade secrets and proprietary know-how. IP has been critical in the research and development and commercialization of biologics. The unique aspects of biotechnology patent law and its complexity compounds the issue for biosimilar companies and represents a fertile ground for biopharmaceutical companies to hinder the development of biosimilars. Examples of issues include the overlap of process and product patents, in addition to such matters as exclusivity period and orphan drug status.
• Supply of Ingredients: Another issue that has emerged is whether there is availability of bulk material and bulk biosimilar suppliers. Several reliable contract biopharmaceutical producers are emerging such as Boehringer-Ingelheim, FujiFilm Diosynth Biotechnologies, DSM-Biologics, and Lonza. However, their focus has been mainly on exclusive custom manufacturing of new biologicals under development by biotech companies or pharmaceutical industry participants active in the development of new biopharmaceuticals. The question is what strategies will contract biopharmaceutical producers adopt with respect to biosimilars? Then there is the question of whether the industry will be able to keep up with the demand.
• Worldwide Pressure: Countries such as China have been producing biosimilars for years and are well suited to partnerships with Western manufacturers. India is moving forward in the biosimilar arena as well. The United States is lagging behind despite the legislative advancements but is still regarded as one of the most lucrative markets.

A limited number of companies will be competing in this market due to concern about approval and regulatory infrastructure of biosimilars, high cost of development and commercialization of biosimilars, and the complex nature of producing and approving biosimilars as a whole. So therefore, companies involved in this area will likely face limited competition among other generic providers and will experience most competition from their brand counterparts.

Kalorama has identified the biopharmaceuticals that have lost patent protection and should be the first products to reach the market, as well as some soon to expire biodrugs, in its report.

About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

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