The European Commission’s pharmaceutical reform will improve access to affordable biosimilar medicines and speed up time to market.Thank you for reading this post, don't forget to subscribe!
Connie Ziegler was diagnosed with rheumatoid arthritis when she was a little girl.
“When I was about a year and a half, my parents told me that my knees were starting to hurt especially. And I didn’t want to walk very far. And it started to hurt. Shortly after that and The first symptoms appeared, I was diagnosed with juvenile rheumatoid arthritis”
He began treatment for his condition at the age of twenty. Then, about ten years ago, doctors advised him to change his usual medication. Biosimilar.
Biosimilars are biological medicines that are copies of approved reference medicines, although cheaper to manufacture and more affordable for patients and health systems.
We went to find out what they were.
What are biosimilars?
The European Medicines Agency defines biosimilars as “A The biological medicine is similar to another biological medicine already approved in the EU (called the ‘reference medicine’) in terms of structure, biological activity and efficacy, safety and immunogenicity profile (the intrinsic ability of proteins and other biological medicines to cause an immune response). Goes).,
They are similar to the name-band medicine (the reference medicine) because they both contain biological material in their composition (for example bacteria, yeast or proteins), although biosimilars will present some variations in their active substance compared to the name-brand medicine. . , This is due to the biological nature of the drug. Biosimilars are the opposite of ‘generic’ versions of biologic drugs because they are exact chemical-based copies of a name-brand drug.
However, biosimilars are still subject to strict EU testing and approval before entering the market. They are assessed by EMA’s scientific committees which handle most marketing authorization applications for biosimilar medicines. Medicines are evaluated according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines approved in the EU.
When are they used?
Biologic drugs and biosimilars provide treatment options for patients with chronic and often disabling conditions such as diabetes, autoimmune disease, and cancer.
,At different times in my life, it took a long time to find the right medication that worked for me. So when I was told I was going to have to switch to a biosimilar I was worried, will this work as well?” Connie Ziegler explains. “I had to tell my doctor about it. But I also thought, if it wasn’t right they wouldn’t have given it to me. So of course I was ready to give it a try. There was another package, and it looked a little different. But for me, there was no change in the way I was treated or the way I felt.,
Like Connie, thousands of Danish patients have successfully switched to biosimilars over the years. Denmark has been a leader in their use. There is also a good tradition of monitoring patients in the country.
Biosimilars in the EU
The EMA authorized the first biosimilar in 2006. Since then, 105 have been approved in the EU.
The EMA’s chief medical officer, Stefan Thurstrup, says other candidates are being closely examined.
,We want to reassure (the public) here that the manufacturer can produce these products in a consistent and safe manner. They delivered what they promised to produce and they demonstrated that on a molecular basis the product is identical to the reference product. Some critics, and some who would be skeptical of biosimilars, would argue that the standards are low. But this is not absolutely correct. We will have the same standards regardless of what type of drug we are dealing with. When generic drugs were introduced 30 or 40 years ago, we had the same concerns. From time to time there are rumors that generic medicines, being cheap, are of low quality. And it’s not true,
Impact of biosimilars
So as soon as biosimilars became available, experts began studying their effects. Bente Glintborg, senior consultant in rheumatology, was involved in many of those studies.
,When biosimilars came to market, it was very clear for us to look at this data in a prospective way: Let’s say, okay, these patients switched from one drug to another. So how do the patients behave, what is the effectiveness of the drug, is it the same?” she explains.
He and his team examined the outcomes of more than 1,000 patients who switched to a biosimilar medicine, compared with a baseline group treated with the reference medicine a year earlier.
,The results were very similar. We could sort out the lines with great difficulty. This showed us that patients’ systems had accepted this switch to biosimilar drugs and that they had the same results as they would have had on the original drug.” she adds.
Recognizing these successes, the European Commission’s pharmaceutical reform seeks to improve the availability of biosimilar and generic medicines to ensure that more patients can access even more affordable medicines.
According to the European Commission, the revised incentives should allow biosimilars to enter the market up to two years from today.
From the Netherlands, the European Medicines Agency will continue to play an important role at the advisory and regulatory levels.