The Past, the Present, and the Future of Biosimilars

The Past

The concept of biosimilars dates back to the 1980s when scientists first began to develop genetically engineered proteins for use as medical therapies. However, it wasn't until the 21st century that the development and regulatory pathways for biosimilars began to take shape.

In the United States, the Biologics Price Competition and Innovation Act (BPCIA) was signed into law in 2010 as part of the Affordable Care Act. This legislation established an abbreviated pathway for the FDA to approve biosimilars.

The first biosimilar product was approved in the US in 2015.

Since then, the use of biosimilars has become more widespread, and they are now used to treat a variety of medical conditions, including cancer, autoimmune diseases, and blood disorders.

In 2005, the World Health Organization (WHO) defined a biosimilar as "a biological medicine that is similar in terms of quality, safety and efficacy to an already licensed reference biological medicine." This definition paved the way for the development of regulatory frameworks for the approval of biosimilars in various countries around the world.

The Current State of #biosimilars

The use of biosimilars has increased in recent years, and they are now used to treat a variety of medical conditions, including cancer, autoimmune diseases, and blood disorders. Many countries have regulatory frameworks in place for the approval of biosimilars, and there are now several biosimilars available on the market.

For example, in the United States, several biosimilars have been approved by the Food and Drug Administration (FDA) and are available on the market.

There are still many debates and controversies surrounding the development and approval of biosimilars. Some critics argue that the approval process for biosimilars is not rigorous enough, while others argue that the high cost of biologics has led to the development of cheaper, but potentially less effective, biosimilars.

In addition, there are concerns about the interchangeability of biosimilars with their reference products. Not all biosimilars have been approved as interchangeable with their reference products, and there is an ongoing debate about the criteria that should be used to determine interchangeability.

However, it is important to continue to carefully evaluate the safety and effectiveness of biosimilars to ensure that they are of high quality and meet the needs of patients.

The Future

The future of biosimilars is likely to be marked by continued growth and expansion, as more biosimilars are developed and approved for use.

The increasing cost of biologics, coupled with the desire to reduce healthcare costs and improve access to medications, is expected to drive the adoption of biosimilars in many countries around the world.

There are also likely to be ongoing debates and controversies surrounding the development and approval of biosimilars. Some critics argue that the approval process for biosimilars is not rigorous enough and that there is a lack of long-term data on their safety and efficacy. Others argue that the high cost of biologics has led to the development of cheaper, but potentially less effective, biosimilars.

Despite these controversies, the use of biosimilars is expected to continue to grow in the coming years, as more biosimilars are approved and become available on the market. Many countries around the world are looking to increase their use of biosimilars as a way to reduce healthcare costs and improve access to life-saving medications.

Biosimilars LatAm - Europe 2023

We have an exciting lineup of speakers and activities planned, to open the business barriers between Latin America and Europe. This is a valuable opportunity for all European industry professionals to learn about the possibilities and challenges when entering and starting cooperation in the LatAm region.

You can discover the topic lineup by downloading the Official Agenda