News of an approval of a biosimilar for a major Roche cancer drug is, we think, evidence that U.S. biosimilars are a growth market opportunity.   At the same time, the approval is a growth limiter for booming cancer drug markets.  Pfizer Inc confirmed Friday that the the FDA approved its biosimilar to Avastin. Pfizer’s Zirabev received approval for the treatment of five types of cancer, including colorectal and lung cancers.

The global market for biosimilar products has grown to be worth $11.4 billion by 2019, adding to the growing strategies of cost savings and improved health outcomes. This according to Kalorama Information’s Biosimilar Market Trends 2019.

Undeniably the top targets for biosimilars are beginning to hit the market. Roche’s Herceptin (trastuzumab), Avastin (bevacizumab) and Rituxan/MabThera (rituximab), and AbbVie’s Humira (adalimumab) will be experiencing the most pressure from biosimilars. Europe is leading the biosimilar charge worldwide. The US is lagging behind due to legal and regulatory issues that continue to plague the industry but is expected to explode in 2023.  Kalorama Information started watching this industry early in 2002 and now a clear growth pathway in the U.S. is seen.

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.

“The global market for biosimilar products has grown to be worth $11.4 billion by 2019, adding to the growing strategies of cost savings and improved health outcomes. This according to Kalorama Information’s Biosimilar Market Trends 2019.

The worldwide prescription generic drug market has stood the test of time and has endured numerous growing pains. However, it has evolved into a formidable and important participant in the complex world of health care. Generic drugs continue to represent one of the greatest values in healthcare and are of great importance in the area of biopharmaceuticals as well because these products are among the most expensive treatments currently on the market. Generic drug manufacturers are poised for strong growth in the future because the patent protection for a host of major biopharmaceuticals will expire and new legislative reforms in the generic drug approval process are facilitating bringing products to market. While there are many issues to address, the outlook for biosimilar promotion is favorable in the next five years.

In 2017, U.S.-based Amgen Inc’s Mvasi was approved by the FDA as the first biosimilar to Roche’s Avastin, which brought in revenue of $6.85 billion to the Swiss drugmaker in 2018.

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