The US has some catching up to do with Europe when it comes to granting regulatory approval to biosimilars. Nevertheless, the global market is set to see a lot of growth over the next few years, according to a new report.
The report, by ResearchAndMarkets, forecasts that the global market for biosimilars will grow from $5.95 billion this year to $23.63 billion by 2023, driven by increased demand for the drugs due to their cost effectiveness, rising incidence of chronic disease and collaborations resulting in enhanced productivity and clinical trial activity. At the same time, issues like the complexity of manufacturing and “innovative strategies” by manufacturers of biologics may conspire to somewhat throttle growth, according to the report. Stringent regulatory requirements may also adversely affect investments.
In the US, as of April 1, 12 companies had publicly announced submissions of Biologic License Applications for biosimilars to the Food and Drug Administration, which had approved nine biosimilars, according to the agency. Meanwhile, the FDA’s Biosimilar Product Development program had enrolled 63 programs as of April 1, while the agency’s Center for Drug Evaluation and Research had received meeting requests related to 31 reference products.
Approved biosimilars include versions of Amgen’s Neupogen (Sandoz’s biosimilar Zarxio); Amgen’s Enbrel (Sandoz’s Erelzi); Janssen’s Remicade (Merck & Co.’s Renflexis, Pfizer’s Ixifi and Inflectra); Roche’s Avastin (Amgen’s Mvasi); Roche’s Herceptin (Mylan and Biocon’s Ogivri); and AbbVie’s Humira (Amgen’s Amjevita and Boehringer Ingelheim’s Cyltezo). Zarxio was the first biosimilar to receive FDA approval, in March 2015.
However, the European Medicines Agency – which covers the European Union and European Economic Area countries – established a legal framework for approving biosimilars in 2003. The first EMA-approved biosimilar was Sandoz’s Omnitrope, a version of Pfizer’s growth hormone Genotropin, which received the agency’s go-ahead in 2006. The FDA also approved Omnitrope in 2006, but did so under the normal drug approval pathway rather than an abbreviated biosimilars pathway.
The aforementioned products target a variety of diseases, including autoimmune disorders, cancers, cytopenias and growth disorders. ResearchAndMarkets’ report noted that the biosimilars market is classified into oncology, chronic diseases, autoimmune diseases, blood disorders, growth hormone deficiency, infectious and other diseases.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Despite ResearchAndMarkets’ forecast, another firm, Market Research Engine, forecast a smaller global market of $9.5 billion by 2022, in a report issued in April 2017. The report nevertheless cited similar drivers of growth.
ResearchAndMarkets also noted that in-house manufacturing – as opposed to contract manufacturing – dominated in 2017 and remains preferred by many biosimilar makers because it allows them to develop the products in their own labs, while eliminating shipping and delivery costs.
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