Role of Biosimilars and Generic Medicines: Healthcare
The Branded medicines typically are either synthetic (they are developed from a chemical procedure), or biological (they are developed from living sources). Synthetic brand-name medicines can be exactly replicated into more affordable generic versions, but because biologics involve extensive, large, complex molecules, they can not. That's where biosimilar drugs come into consideration and become usable. When drug manufacturers receive US FDA approval on a new medicine, they obtain a patent ensuring that no other existing manufacturer can develop or sell the medicine for as long as the patent is active, generally 20 years.
Biosimilars or Biosimilar medicines are often confused with generic medicines. Both biosimilars and generics are marketed as economical versions of costly brand-name medicines. Both are available when medicine companies' original patents on costly new medicines expire. Biosimilar and generic medicines are designed to have identical clinical effects as their prices counterparts. The fact is that biosimilar and generic medicines are quite different, specifically because while biosimilar medicines are highly identical, but close enough in duplication to attain uniform therapeutic and clinical outcomes, generic medicines are similar to the actual product in chemical composition. Another utmost difference is that biosimilars are modeled after medications that use living organisms as vital ingredients, while generics are copies of synthetic medicines.
Biosimilars are developed from living organisms and do not contain any identical ingredients to their brand-name substitutes, they require some testing, so they cost more than generic medicines, but less than branded biologics. On the other hand, generics are chemically similar to the actual brand-name medication and, as such, the cost of generic drugs is significantly less because they do not require much testing.
In general terms, biosimilars are 15% to 20% economical because of the amount the drug manufacturer has to invest in testing and generic medicines cost 40% to 50% less than their brand-name alternatives.
So far, the Food and Drug Administration has approved some biosimilars which are as follows:
- Filgrastim-sndz (Zarxio)- approved in 2015
- Bevacizumab-awwb (Mvasi)- approved in 2017
- Trastuzumab-dkst (Ogivri)- approved in 2019
Key Statistics: According to a report by IMARC Group:
- In 2019, the global generic medicines market accounted for a value of 367 Billion USD, with a CAGR of 5.7 percent during the time span of 2014 to 2019.
- The global biosimilars market, which was valued at 5.5 Billion Dollars in 2018, is supposed to mushroom with a CAGR of 38.21 percent during the forecast time span of 2019 to 2025.
- At present, Europe is the most lucrative territory for the biosimilars market and accounted for nearly 74 percent of the global market share and the market is attaining traction in the North American territory at a quick pace.
Biosimilar medicinal products were developed for several diseases including chronic diseases like cancer, cardiovascular disease, etc. The oncology disease section is the key to the biosimilar drugs market. The oncology disease application in the biosimilar drugs market is increasing at a CAGR of 41.58 % through the forecast time-span. Another therapeutic section like autoimmune diseases such as inflammatory
bowel disease, arthritis, and psoriasis is attaining traction.