Biosimilars is defined as a type of biological product that is similar to another drug, which has already been licensed (approved) by the US FDA or European Medicines Agency. Due to their high degree of similarity with the biological reference product, they have no clinically evidenced and meaningful differences from the reference product in terms of quality, safety or efficacy. These drugs are also coined as follow-on biologics and are mostly derived from biological sources such as bacterium and yeast. The constitution of the biosimilar drugs can be either small molecules such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies. Biosimilars are increasing gaining prominence given the loss of exclusivity of big branded drugs. In Europe, biosimilars can be marketed through independent applicant following expiry of patent and market exclusivity periods of the reference product. A good example for this is Pfizer acquisition of Hospira, to gain access to the latter’s attractive biosimilars portfolio. Regulatory harmonization, naming and labelling, innovative licensure norms and route to market for the biosimilar drugs are issues expected to gain attention and traction from big drug makers in the forthcoming years.
Biosimilars and Follow-on Biologics Market: Drivers and Restraints
Drivers for the biosimilars market include big brand name drugs losing patent extensions, cuts in healthcare costs across nations, forming of incentivized pricing policies by companies in order to access high growth pharmerging markets and good development in pharmacovigilance procedures across the globe. Other factors increasing the demand for biosimilar drugs include rising disease incidences across the globe and better access to healthcare for all nations.
Restraints for the market include constraints in developing and registering biosimilar drugs and the complexity in the manufacturing processes. The drugs are difficult to verify and have to undergo complex regulations. Further, the drugs are different from each other due to variability in raw material and in the manufacturing process, which is expected to deter the future development of biosimilar drugs. There are also risks in having an increase in the versions of an identical biosimilar drug.
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Biosimilars and Follow-on Biologics Market: Segmentation
Biosimilars and Follow-on Biologics Market can be segmented into these following ways:
- Segmentation by product class
- growth hormones;
- alfa interferons;
- monoclonal antibodies;
- beta interferons;
- low-molecular-weight heparins (LMWH).
- Segmentation by application
- Rheumatoid arthritis
- Segmentation by regions
Biosimilars and Follow-on Biologics Market: Overview
Biosimilar market is expected to gain prominence over the forthcoming years due to leading biologic drugs expected to lose exclusivity over the next seven years. Further, biosimilar drugs, once formed, are expected to generate cost savings for the patient population. Competition is expected to be limited in the market as the drugs are expected to be formed using various types of innovative technologies. Biosimilars may generate smaller savings for drug makers because of their complexity as well as regulatory challenges of getting FDA approvals.
Biosimilars and Follow-on Biologics Market: Region-wise Outlook
Depending on geographic regions, biosimilar drug market is segmented into seven key regions: North America, South America, Eastern Europe, Western Europe, Asia Pacific, Japan, and Middle East & Africa.
In terms of geography, Europe dominates the market, followed by Asia-Pacific. However, rising technological advancement in healthcare and systematic drug review process will drive the markets over North America, Japan and other regions. Europe dominates the biosimilars market driven by technically advanced healthcare infrastructure and high patient awareness & regulatory harmonization. Increasing funding for development of biosimilar drugs, availability of high-quality research infrastructure and strategies developed by drug makers to restrict entry of new players. Emerging markets include Eastern European countries followed by countries in Eastern Africa. Rising disease incidences in these countries is expected to prove favorable for the growth of the biosimilar drug market.
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Biosimilars and Follow-on Biologics Market: Key Players
Some of the key players in biosimilar market are Pfizer Inc. (AC. Hospira), Sandoz International GmbH, , Teva Pharmaceutical Industries Ltd., Dr. Reddy’s Laboratories, Biocon Limited, Mylan, Inc. , Amgen, Celltrion Inc., Roche Diagnostics, and Merck KGaA.