For Major Biopharma Products, Competition is Coming

For Major Biopharma Products, Competition is Coming

(MARY ANNE CRANDALL, Kalorama Analyst Contributing) - Well known brands like Humira and Botox could soon face myriad competitors, according to Kalorama informations new report on biosimilars. And this is a new development for an industry that's been largely unchallenged due to the complexity of their formulations.  With biosimilars, close copies of major biopharmaceuticals, the competitive situation is changing in some interesting ways.   The global market for biosimilar products has grown to be worth almost $4.4 billion, adding to the growing strategies of cost savings and improved health outcomes.  Kalorama's  Biosimilars: Global Market, Trends and Competitor Analysis. finds worldwide interest in biosimilars is gaining momentum since our last visit to this market in 2013.   

Biosimilars a New Factor in the U.S. Biopharmaceutical Market

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 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.

Despite the benefits, both economical and to patient health, the market has been slower to develop than generic drugs 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.  There's more development of the biosimilar arena; however, the United States is still lagging due to regulatory stumbling blocks. Some of the biggest-selling biological drugs developed during the first phase of the biotechnology revolution in the 1980s, including human growth hormone (hGH) and insulin, have lost patent protection. This opens up the market with a potential of $40 billion and the market is growing at over 30% per year if the regulatory hurdles can be overcome.

 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 is market researcher in biotechnology, pharmaceuticals and in vitro diagnostics.   Its report is designed to provide a comprehensive look at the various strategies being used by select worldwide generic companies in exploring the emerging area of biosimilars, the issues and trends that are shaping the marketplace, and the potential feasibility of providing biosimilars within the United States regulatory environment.

Major Biosimilar Companies in the Market

. These close copies of biodrugs are coming to U.S. markets and the charge is lead by five companies.   Kalorama details the efforts of these companies in its report: Biosimilars: Global Market, Trends and Competitor Analysis.  In addition to these five household names: Sandoz, Pfizer, Eili Lilly, Merck and established biopharma player Biogen.    There are many companies in this sector and we’ve documented that in our report,  but these five have all really invested in biosimilar pipelines and are expected to make strides in the industry . These companies are targeting the big drugs: Remicade, Rituxan, Lantus, Neulasta.” 

 The report says early development efforts  is strengthening.  Biosimilars targeting Herceptin, Lucentis, Erbitux are up-and-coming.   Nor is it just the case of small competitors developing drugs to compete with profitable brand names.  The report says big pharma is taking a specialized interest in biosimilar development and commercialization.  Major development agreements between niche biotech and big pharma is the trend - small biotech research combined with big pharma's commercialization and financial strengths.  

Less Known Biosimilar Players 

 The report lists many other smaller competitors who could make waves in the field.  Among them are:

  • Dr. Reddy’s, based in Hyderabad India, is known in the US market.  They were the first company in India to develop a biosimilar in-house. Grafeel is a human granulocyte-colony stimulating factor containing filgrastim. It is indicated for treatment of chemotherapy-induced neutropenia and in bone marrow transplants. Grafeel is marketed in India, Sri Lanka, Ukraine and Brazil. The company also offers Reditux, a generic development of Rituxin, a chimeric murine/human anti-CD20; it is the world’s first biosimilar monoclonal antibody. Dr. Reddy’s has several other products that are on the market or in the late development stages.
  • Mumbai-based Wockhardt is another leading Indian player in the biosimilar arena. The company has introduced three successful products including Biovac B, a hepatitis B vaccine, Wepox, a recombinant erythropoietin for treating anemia and Wosulin, the first r-DNA insulin development and manufactured outside the United States and Europe.
  • Fujifilm Kyowa Hakko Kirin’s is the result of a joint venture with Fujifilm and Kyowa Kirin Biologics Co Ltd. to develop a biosimilar for bevacizumab and anti-VEGF humanized monoclonal antibody.   The drug is used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma.  Through this partnership, the company wants to attain a leading position in the expanding biosimilar market.   brand-name filgrastim GRAN. In 2016, the company’s first product, “FKB327,” completed its Phase III trial and FKB238 Phase III trials  (bevacizumab) has begun.
  • Seoul-based LG Chem Ltd. expects to launch its first biosimilar in Korea and Japan in 2018.   “LBEC0101” is a biosimilar for Enbrel. The company entered into an agreement with Mochida Pharmaceuticals to commercialize the product in Japan. A second biosimilar, LBAL – biosimilar of Humira, is in Phase III clinical trials.
  • Gedeon Richter is the largest biotechnology and pharmaceutical company in Hungary and middle sized globally, present in nearly 40 countries.   The company is fervently pursuing biosimilar development. It has established two collaborative agreements with Mochida Pharmaceutical to develop several Richter biosimilar products in 2010 and secondly, Stada, which it has two biosimilars and two monoclonal antibodies in development In July 2016, Richter’s biosimilar, teriparatide – a treatment for osteoporosis – received EC marketing authorization.  The company has a portfolio of biosimilar monoclonal antibodies including trastuzumab.  

By no means is the biosimilar market limited to these ten companies.  There are constant moves as companies develop products while protecting their own patents.  Kalorama’s report details the efforts of scores of companies.  It also establishes market forecasts and predicts which biodrugs are under the heaviest competitive threat.  The report is available at:  It is also part of Kalorama Information’s Knowledge Center.