The European Commission's pharmaceutical reform would improve access to cheaper biosimilar medicines and speed up the time it takes to access the market.
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00:00 Connie says she does not remember when her health problems first started.
00:07 When I was about a year and a half, I was told by my parents that my knees especially started hurting and I didn't want to walk very far.
00:20 I started having pain not that long after that, the first symptoms. I was diagnosed with juvenile rheumatoid arthritis.
00:31 [Music]
00:38 Now 54, Connie works as a project manager here at the Danish Rheumatism Association in Copenhagen.
00:44 Her treatment started in her early 20s. Then some 10 years ago, doctors advised her to change her medication to biosimilars.
00:53 Biosimilars are biological medicines whose structure, efficacy, safety, dosage and side effects are highly similar to those of the approved reference medications.
01:03 But they are cheaper to manufacture and more affordable for patients and healthcare systems.
01:09 In periods of my life, it had been taking quite a while to find the right medication which were good.
01:15 So I was concerned that now when I was told I'm going to switch to a biosimilar, would it work just as well?
01:22 So I really needed to address this to my physician. But I also thought that, well, they would not give it to me if it wasn't okay.
01:33 So of course I was willing to try it and use it. It was another package and it looked a bit different.
01:40 But for me, I didn't have any changes in the way it was treated or the things I felt.
01:49 Like Connie, thousands of Danish patients have successfully switched to biosimilars these last years.
01:56 Denmark has been a frontrunner in their use.
01:59 The country also has a good tradition of monitoring its patients.
02:04 As soon as biosimilars were available, experts here started studying their impact.
02:10 Senior consultant for rheumatology, Vente Glindberg, was involved in a number of those studies.
02:17 When the biosimilars came on the market, it was quite obvious for us to then look at these data in a prospective manner and say,
02:23 "Okay, these patients, they switched from one drug to another. So how do the patient outcomes behave?
02:29 How is the drug effectiveness? Is it the same?"
02:32 We identified more than a thousand patients who switched, an historic co-group of patients treated with the originator drug the year before.
02:39 And then we then compared the outcomes. They were very much identical.
02:43 We couldn't hardly disentangle the lines.
02:45 So that illustrated to us that the patients accepted this switch to the biosimilar drug
02:51 and had the same outcomes as they would have had on the originator drug.
02:55 Acknowledging these breakthroughs, the European Commission's pharmaceutical reform wants to improve the availability of biosimilars
03:03 and also generics to ensure more patients can get access to more affordable medications.
03:09 According to the European Commission, modulated incentives should allow biosimilars to enter markets up to two years earlier than today.
03:18 From the Netherlands, the European Medicines Agency will keep playing key roles at consultation and regulatory levels.
03:28 The agency authorized the first biosimilar back in 2006, and since then, 105 have been approved in the European Union.
03:37 Other candidates are under strict scrutiny, says the EMA's chief medical officer.
03:44 What we are looking for here is to reassure that the manufacturer can produce these products in a consistent and safe manner,
03:53 that what they produce is actually what they promised to produce,
03:57 and that they have demonstrated that the product, on a molecular basis, is similar to the reference product.
04:06 Some critics and some who doubt biosimilars would argue that the standards are lower, but that's actually not right.
04:13 We will put the same standards, independent on what type of medicines we are dealing with.
04:17 When generics was introduced, maybe 30, 40 years ago, we had the same concerns.
04:23 People were concerned about generics. There are still rumors around from time to time that generics, because they are cheaper, are for lower quality.
04:32 And that's not true.
04:34 Having rheumatoid arthritis is a chronic disease, so it's also not important just how it is right now, but also in 10 years or 20 years or even 30.
04:45 So it's very important that you have the right treatment, and it's a very good thing that more people can benefit from these cheaper medications.
04:56 (upbeat music)
04:58 [MUSIC]