Biosimilars have long been touted to be the future of medicines, and after a decade or so, we can say that the future is here. Biosimilars already constitute a significant amount of the pharmaceutical market as they are relatively cheaper than biologic drugs in the US, Japan, and Europe. For instance, with 21 approvals in Europe, biosimilars are 30% less expensive than conventional biologic drugs. However, only 18% of physicians know about these similar variations of biologic medications.

Patent Cliffs Looming on the Horizon

With the FDA expecting to review more biosimilar applications in 2020 because 66 biologic U.S. patents are expiring between 2020 and 2025, the biosimilar market is on the cusp of a significant boost, cracking new markets. Moreover, the patent cliff that these drugs are facing represents billions of dollars in annual drug sales.

It is forecasted that since the US and Japan are spending the most in the biologic markets, they will become the largest and leading biosimilar market hubs. It is expected that by 2020, at least 50% of the market will belong to off-patent drugs, creating a vast expansion pocket for biosimilar drugs. The first biosimilar approval came in the US in 2015, and with 12 biologic patents expiring in 2020, they are expected to competitively takeover the biologic market. Additionally, it is predicted that biosimilar will constitute 4% to 10% of the biologic market by 2020.

This is beneficial to governments and people as biosimilars promise to be half the price of original biologic drugs. Accelerating biosimilar companies’ progress and helping them expand exponentially every year; case in point is the Latin American pharmaceutical market, which will benefit millions of patients as well as the economy.

A Latin-American Case Study

For a long time, big multinational pharmaceutical companies have been trying to enter and capture the LATAM pharma market. The promise of cheap, yet skilled labor, more affordable production costs, looser regulations, and government boosts have enticed big pharma companies from the start of the decade to enter Latin America. However, they had to fiercely compete with the local and regional pharma companies that already have a firm hold on the market. Moreover, some of these local pharma companies consolidated to form more prominent pharma corporations and expanded their operation into neighbouring Latin American countries.

Therefore, it is not surprising that there is a flourishing biosimilars industry in Latin American countries like Brazil, Argentina, and Mexico. Brazil leads the biosimilars market due to its large population and market capacity.

However, on the international stage, the Latin American biosimilar industry faces some excruciating challenges because of the exorbitant cost of R&D and clinical trials, as well as stricter regulations considering they have to compete with companies from developed nations like the US and Japan.

What Can Be Done?

In order to circumvent these challenges, efforts should be made to develop the kind of prudent and high-standard infrastructure that helps in efficiently evaluating and analysing the necessary clinical information required for accurate patent registration and quality comparative clinical trials. Additionally, it should have the ability to meet international safety standards and carefully balance the risks and benefits compared to the original drug. Finally, technical advancements have to be made to improve the effectiveness of biosimilars and pharmacovigilance to ride the biosimilar development wave.

Considering how biosimilar drugs currently constitute 50% of medical expenditure worldwide, there is no doubt about their efficacy. Additionally, biosimilar drugs benefit the health care system of developing countries, empowering them to achieve complex treatments at subsidized costs.

In conclusion, the aggressive expansion of biosimilar industries in Latin American markets or any market worldwide leads to cost-effective prices, newer drugs, and the availability of better alternatives at a global level.