The boom market segment of pharmaceutical sector is “Biologics”. Biologics are predicted to hold six of the top 10 rank in the pharmaceutical sector by 2014.They broadly relate to substances made via biotechnology from living cells (i.e., recombinant DNA technology, controlled gene expression, or antibody technologies) which have made numerous novel medicines for serious and severe diseases like cancer, diabetes, anemia, rheumatoid arthritis, and multiple sclerosis accessible. The same protein as the original drug may now be produced and marketed by other pharmaceutical companies as the patents on the first introduced biologic therapies have started to lapse. These products are referred to as Biosimilars. According to USFDA, Biosimilar is a product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product (originator product) in terms of quality, safety and efficacy. Omnitrope®, (a somatropin biosimilar) was the first Biosimilar which was approved in Europe in 2006. They exist through many different names, including follow-on biologics, biocomparables, biogenerics (outdated and in disuse), similar biotherapeutic products (SBPs), and subsequent entry biologics (SEBs). Earlier on, Biosimilar are replicas of approved products that have been shown to be similar to the original product, they are not generics because molecular microheterogeneity cannot be precisely replicated due to natural variability and the more complicated manufacturing processes used for biological medications.
The need of biosimilars helps healthcare to access more economical treatments, as and when compared to reference products, their cost-effectiveness ranges from 20 to 25%. The advantage from a regulatory perspective is that the clinical development programme for the reference biologics molecule need not be repeated in its entirety for the biosimilar planning process. This benefit lowers prices for both producers and consumers. Furthermore, it prevents many volunteers and patients from participating in redundant trials and compared to the branded original biologics, the approval process for biosimilars is far more efficient, straightforward, and affordable. Healthcare practitioners will have a wider selection of medications to recommend as a greater number of biosimilar become accessible. With their help, more patients might have access to a secure alternative therapy of choice. Affordable biosimilars may make it possible for more patients to receive these treatments earlier in the healing process. In some cases, taking biosimilars earlier in the therapeutic process may improve patient outcomes while also enhancing quality of life. Also, the availability of more therapeutic alternatives rises, which also raises the level of competition. By doing so, high-value medications may become less expensive, freeing up money that are crucial for healthcare systems. Biosimilars will be more frequently encountered by healthcare professionals as prospective therapeutic choices to take into account for their patients across a range of chronic or fatal conditions. The variety of instructional resources available on biosimilars is also probably going to grow, which might provide healthcare experts more confidence when prescribing biosimilars.
In conclusion, the development of biosimilars is a result of the society’s and the medical community’s joint efforts to create a health system that is more cost effective. Their successful integration into current medical practise will ultimately aim to improve healthcare for everyone.