Approved biosimilars have an “identical pharmacological effect” on the human body. This is stated in the currently published guide to biosimilars by the Drug Commission of the German Medical Association (AkdÄ). Biosimilars correspond to their reference medicinal product in terms of “quality, biological activity, safety and efficacy”. An accolade for biosimilars.
Biological medicines – complex and sensitive
Biologicals and biosimilars are protein-based drugs. They are produced in lengthy and cost-intensive biotechnological processes in living, genetically modified organisms or cells. The amino acid sequence, stays the same, however, as a result of the production in living organisms, the proteins obtained differ in their three-dimensional structure and could thereby trigger different immune responses in the human body. However, clinical data suggests that this is highly unlikely. The batch of a biological is never identical to the previous batch due to the said manufacturing process.
Biosimilars are medicinal products containing a version of the active substance of an already approved biological. The difference between biosimilar and reference medicinal product is no greater than that between the different batches of a biological. This variation is called microvariability or microheterogeneity.
The bioengineered drugs have a delicate structure which makes them different from the unevenly more robust chemically produced medicinal products. Temperature fluctuations and even vibrations can break up the tertiary structure of the drug and make it ineffective.
The fight for biosimilars
Why are biosimilars so heatedly debated? Indeed, you could even call it a battle that has broken out between the market newcomers and the patent-protected biologicals. It is about money and a lot of it. Biologicals generated gross sales of 7.8 billion EUR in 2016 according to the AOK Scientific Institute (WIdO). This comes as no surprise for a syringe of the rheumatoid Humira is sold for over 1000 EUR.
Biosimilars, on the other hand, are around a quarter cheaper than biologicals. Biosimilars can thus save costs in the healthcare system for health insurance companies. The WIdO has determined that the German health insurances saved 77 million EUR last year by switching to biosimilars. And there is still room for further savings. The WIdO sees a potential of another EUR 214 million. With the money saved more patients could be treated with bioengineered drugs.
By 2020 patents of twelve of the highest-selling drugs are running out. These include Rituximab (2013), Infliximab (2014), Trastuzumab (2014), Etanercept (2015), Enbrel (2015), Remicade (2015) and Humira (2018). The manufacturers of the reference drugs had partly tried to slow down their competitors by handing in follow-up patents. Yet, they were not successful. The running out of patents will open the door for biosimilars to the markets a bit wider.
Biosimilars today and tomorrow
The first genetically engineered drug worldwide was human insulin, which was approved in 1982 in the USA and Germany. In 2006, the first biosimilar was approved in the European Union – Omnitrope ©. To date (as of June 2017), 32 biosimilars were accepted by the European Medicines Agency (EMA). Mostly for the two indicative areas of rheumatology and oncology. Although the biosimilars have a great potential to relieve the health care system financially, they are not yet sufficiently spread in the health care system. In 2015 of 656.65 million biosimilar-capable daily doses, only 9.22 million of them were replaced by biosimilars. There are still reservations about the counterfeit products, doctors are reluctant in their prescription, and discount agreements by the health insurance companies makes it difficult for biosimilars to spread. Perhaps the published guideline of the Drug Commission of the German Medical Association (AkdÄ) changes that attitude towards biosimilars. Not least in the name of the patients this switch would be good.