Biogenerics drugs are the biological products manufactured after end of patent of innovator biopharmaceuticals. Biogenerics also known as biosimilars in Europe, follows-on-biologics in US and subsequent entry biological in japan. 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. Biogenerics drugs provide effective treatment for number of serious and life-threatening illness because of their high specificity and activity. Biogeneric are more complex compared to small molecule drugs. Their quality and safety are highly dependent on the process of production (choice of cell type, development of the genetically modified cell for production, etc.), purification and formulation. The constitution of the biogeneric drugs can be either small molecules such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies. Biogeneric drugs are increasing gaining prominence given the loss of exclusivity of big branded drugs. In Europe, biogenerics can be marketed through independent applicant following expiry of patent and market exclusivity periods of the reference product. Regulatory harmonization, naming and labelling, innovative licensure norms and route to market for the biogeneric drugs are issues expected to gain attention and traction from big drug makers in the forthcoming years.
Biogeneric drugs market is expected to increase in forecast period due to increased treatment options, value added services to care patient and healthcare community. Due to drugs introduces competition, increasing affordability of biologics which delivers saving for healthcare systems are the same factors which increase biogeneric drugs market. Introduction of affordable, high-quality biogenerics drugs improves access to life changing medicine for patients worldwide. Opportunities for generic drug products is huge but there are regulations that must be adhered to when strategizing the best ways to maximize a company’s return. Government regulation may be adhere the growth of drug development investment or planning an entry into a market with a new biogeneric products.
The global Biogeneric drugs market is segmented on basis of product type, end user and geography:
- Segmentation by Product Type
- Growth hormones
- Monoclonal antibodies
- Segmentation by Indication Type
- Alzheimer’s disease
- Multiple sclerosis
- Segmentation by End User
- Hospital and clinics
- Research centers
Biogeneric drugs 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, biogeneric 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. Biogeneric drugs may generate smaller savings for drug makers because of their complexity as well as regulatory challenges of getting FDA approvals.
Regionally, the global Biogeneric drugs market is segmented into five key regions viz. North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America is expected to lead the global market due high adoption of advanced products and increasing investments in research and development activities in the region. Biogeneric products are suspected to have a significant impact on the pharmaceutical industry in the U.S. and Europe. However, the Biogeneric drugs market in the Asia-Pacific region is expected to witness significant growth rate over the forecast period. Due to increased competition with the accelerated approvals of biogenerics drugs and rapid introduction to the market place, market conditions will have to evolve to adapt.
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Some of the players operating in the global Biogeneric drugs market are Sandoz International GmbH, Teva pharmaceutical industries ltd., Stada Arzneimittel, Mylan N.V., 3SBio Inc., Qilu Pharmaceutical Co.,Ltd., Shanghai Fosun Pharmaceutical (Group) Co., Ltd, Tonghua Dongbao Pharmaceutical Co., Ltd.., beijing shuanglu pharmaceutical co. ltd, Biocon, Dr. reddy’s Laboratories, Ranbaxy Laboratories Limited, Reliance life sciences, Intas Biopharmaceuticals ltd, Probiomed, Biosidus S.A., AMEGA Biotech S.A., Celltrion Inc., LG life Science, Dong-A Pharmaceutical Co., Ltd., Biocad and others.