The Race is On for Biotechnology Drugs

Hundreds of companies worldwide are on the hunt for cheaper copies of costly biotechnology drugs, with >700 biosimilars now in development or already approved, according to a major study of the sector.

Biotechnology medicines account for 6 of the 10 biggest-selling drugs in the world today, led by AbbVie's $12 billion-a-year rheumatoid arthritis injection adalimumab (Humira^®). The total market for biological medicines could exceed $250 billion by 2020, but many of today's top-selling drugs are losing patent protection or will do so in the next few years. This has opened the doors for companies with the technical ability to make copycat versions.  

Despite the hurdles, a total of 245 companies in different countries have now joined on as developers, manufacturers, and suppliers of biosimilars or follow-on biologics, according to a study from Thomson Reuters.

Biosimilars are expected to account for approximately one-quarter of the $100 billion sales stemming from off-patent biological drugs by the end of the decade.

South Korea and Brazil stand out as pioneers of biosimilar drug development, with India's large pharmaceutical sector also anticipating a thriving market for these products.

While biosimilars could slash the cost of treating diseases such as cancer and rheumatoid arthritis in much the same way that generics have curbed spending on traditional medicines, the impact is likely to be more gradual for several reasons.

Biosimilars medicines are typically offered at a 20% to 30% discount to brand name drugs compared with an approximately 90% discount associated with conventional generics. Also, many doctors are cautious about the use of biosimilars, as they may vary slightly from the original product.

In addition, to this point, the regulations surrounding biosimilars have been unclear. Europe approved the first biosimilar drug in 2006, but the United States is only now considering the first applications.

The first official application for a biosimilar was filed in the United States in July by Sandoz, which intends to create a copy of Amgen's filgrastim (Neupogen^®) for patients with low white blood cell counts.—Kerri Fitzgerald

Source: Thomson Reuters. 2014; Hundreds of firms join global hunt for copycat biotech drugs.