EU launches medical generic and biosimilar products

In the pharmaceutical field, generics and biosimilars have proven to be an essential way to combat the rising costs of medicine all the while maintaining the offer of high-quality products that satisfy both patients and buyers alike. Hence, such products keep in line the need to have medicine and healthcare affordable and accessible to all. When the announcement was made in April 2019 that an easier production of generics and biosimilars in the European Union will begin in mid-2022, many parties involved within the healthcare and pharmaceutical industry were enamoured.

Simply put, a generic is defined as a medicinal product that shares similar qualities or compositions as the reference product or its original. Likewise, a biosimilar share the same characteristics, biological composition, safety and efficacy tributes to the reference medicinal product. While conventional generic medicines have more chemical components, biosimilars are composed of more complex compounds like proteins, sugars or nucleic acids. However, both products are granted regulatory approval and measures in defined daily dosages measured by the World Health Organisation (WHO).

The generics and biosimilars industry has been doing well in other countries. For example, in the US, these medicinal products in the pharmaceutical field have been quite practical for patients and buyers as the prices are relatively lower than the originals. In fact, according to the 2017 Generic Drug Access and Savings Report, medical companies who have bought these generic and biosimilar products have earned savings of a total of $44 billion. In total, the U.S. healthcare system has saved $1.67 trillion.

With a strict EU patent law in force, it was challenging originally to have generics and biosimilars to be circulated in and around the EU. Such drawbacks meant that certain drugs were limited, inaccessible or quite expensive for purchase. What EU members and delegates wish to do presently is to help eliminate these barriers. Henceforth, the recent patent law that was passed in the European Parliament in April this year hopes to relax the existing laws and regulations under medicinal licencing and protection law.

The new EU regulation, which will take effect on July 2022, will allow Europe generics manufacturers to start the production of these products as well as exportation to third countries when needed. Furthermore, in some cases, manufacturers will be able to make their drug copies for market use within Europe even months before the original patent production expires. In addition, the law will further allow pharmaceutical companies exclusive access into the EU market for up to 5 years after the 20-year patent protection test phase and pre-market trial period for their original medicines.

Advancing further with the generics and biosimilars industry will do well for the healthcare system in the EU. Experts and officials are already predicting the benefits the region will gain when the new law will be enforced.

EU commissioner for Internal Market and Industry Elzbieta Bienkowska mentioned during the announcement that,

“We are eliminating a major competitive disadvantage for EU producers, who will soon be able to compete on the highly competitive world markets on equal terms. »

It was further mentioned that it is expected for the industry to increase in sales across Europe to at least 1 billion euros annually or more, especially with the new export opportunities with neighbouring countries. It was also said that within approximately 10 years, there will be a boost in up to 25,000 jobs entering the EU pharmaceutical market.

References:

1. Generics and biosimilars to be launched faster in Europe. HandelsBlatt
2. Health At A Glance OECD 2017 Report, OECD
3. Generics and Biosimilars Drive Access and Savings for the U.S. Healthcare System, June 2017, Mylan
4. Industry touts savings potential of generics and biosimilars, 2018, Biopharmadive