Cost Savings, Health Through BiosimilarsBy Miriam Bello | Fri, 07/02/2021 - 17:19
Numerous therapies and new molecules are making their way to the market. Among them are biosimilars, which thanks to their lower costs and excellent qualities can bring diverse opportunities for patients and the pharmaceutical industry.
Biologics, or biological medicines, are made by living organisms and extracted through highly complex processes. They must be handled and administered under carefully monitored conditions. This category of medications includes gene and cell therapies, therapeutic proteins, monoclonal antibodies and vaccines, among many other products.
A biosimilar medicine is a biologic product that is approved based on its demonstrated similarity to a previously approved biological medicine, explains Pfizer. In this scenario, the “original” biologic product is known as the reference product and the biosimilar should not have clinically meaningful differences in terms of safety and effectiveness. To qualify as a biosimilar, a product must only have minor differences in its clinically inactive components to the reference product.
According to The Biosimilars Council, biosimilars can reduce costs for patients by offering a lower-cost treatment and more options. These benefits are based two factors:
- Developing a biosimilar costs less than a reference biologic. Biosimilars usually take eight to 10 years to develop at a cost between US$100 million and US$200 million. The cost of developing a new drug, on the other hand, can climb up to US$2.6 billion. As a result, manufacturers have fewer expenses to recoup, theoretically allowing for biosimilars to have lower list prices.
- Biosimilars introduce competition into the healthcare system. As the number of treatment choices increases for a particular disease or condition, manufacturers are incentivized to reduce the prices of their products to maintain or increase market share.
Biosimilars are less costly than original biologic agents primarily because biosimilars do not have to undergo the same intensive clinical development process, explains an article on NCBI. Furthermore, biosimilars do not incur high costs for marketing, market access, and post-marketing research and development.
The penetration of these products, however, is still very low. Currently, Mexico has only approved biosimilars for filgrastim, follitropin alfa, infliximab, interferon alfa 2b, interferon beta 1b, insulin glargine, rituximab and somatropin. The limited number of competitors affects access to medicine and healthcare expenditure, explained M. S. Nagendra, Director General of Zydus Pharmaceuticals to MBN. “The Mexican government should take a look at the biosimilar market and players and allow more competition by adapting the regulatory framework, favorable to investors and end users,” said Nagendra.
Despite of the cost saving opportunities biosimilars bring to the table, companies still face numerous challenges to enter this complex, limited market. Nagendra pointed out that to dabble in this market, companies need to have a concrete business strategy. More importantly, they need the financial support for such an investment. “Costs are very high to meet the current regulatory requirements and this is not an investment every company is willing to make,” said Nagendra. “The international biosimilars market represents around US$25 billion and Zydus is targeting a portfolio worth US$65 billion with a substantial variety of 21 products.”
Mexico could also see attractive opportunities in the manufacture of biosimilars thanks to its strong pharmaceutical legacy and history, said Nagendra. Both international and local players meet strict regulatory requirements but there are still opportunities and gaps in terms of technology and innovation. “If the Mexican government encourages investors for API manufacturing, it would further strengthen the local pharma industry.”