Advanced and affordable medicines
Biological medicines offer new treatment options for multiple diseases. The reference products are patent-protected and therefore are often expensive. With patent expiry, biosimilars offer the same treatment possibilities as the reference product in a more affordable way.
Most people think that all medicines are made from chemically manufactured molecules. However, there are actually medicines that are derived from living cells, which are being modified so that they produce active substances that can be used in biological medicines. Biological medicines are being used to treat several health conditions, such as cancer, diabetes, rheumatoid arthritis, and osteoporosis.
When the patents for those reference medicines expire, medicines that are comparable to the reference products can be manufactured and made available to patients. They are known as biosimilar medicines.
As the name suggests, they are highly similar to the original medicine, and they are of the same quality, efficacy, and safety. Thus, they can be used to treat the same conditions as the original biopharmaceutical drugs. However, they are generally more affordable, which gives more patients access to these hi-tech medicines.
Are biosimilars the same as generic medicines?
No. Generic medicines have exactly the same structure as the original "small molecule", such as paracetamol or antibiotics. Biosimilars are not exact copies of the biopharmaceutical active substances. They are made of the living cells and are often large, complex modules. The differences between reference biologics and biosimilars are kept within very strict limits, so one can be sure they work in the same way as the reference product.
Is a biosimilar as safe and effective as the original drug?
Absolutely. We have to prove to the European Medicines Agency (EMA) that the quality, safety, and efficacy of our biosimilar meet targets that gained approval for the original drug. But like all medicines, biosimilars must be administered correctly for their approved indication. You will find the necessary instructions in the prescribing notes and the packaging leaflet.
How are biosimilars being approved?
Since the biosimilar has a very similar structure and the same biological activity as the original drug, its quality and efficacy are already known. The studies that we carried out are to verify biosimilarity and safety. As a result of showing comparability on a scientific basis, a biosimilar can be used instead of the reference product.
Because of the way biosimilars are developed, the conclusion that the safety and efficacy shown in studies for one condition will remain applicable to other conditions that were studied for the original reference drug is justified. This process is known as extrapolation and is also used for original medicines in certain cases, for example when a new dosage form is being introduced.
Every decision on whether a new clinical study must be carried out for a biosimilar is issued by the EMA.
Do you have to repeat all the studies to prove a biosimilar is effective?
That is not necessary. Since the biosimilar has a very similar structure and the same biological activity as the original drug, quality and efficacy are already known. The studies were carried out to verify biosimilarity and safety. As a result of showing comparability on a scientific basis, a biosimilar can be used instead of the original product.
How can a biosimilar be approved for a disease when no clinical studies have been done?
Clinical studies have to be performed, but not for each condition. Because of the way biosimilars are developed, it is reasonable to conclude that the safety and efficacy shown in studies for one condition, will remain applicable to the other conditions that were tested in the study for the original reference drug. This process is known as extrapolation, and is also used for original medicines in certain cases, for example when a new dosage form is being introduced.
Every decision on whether a new or additional clinical study must be carried out for a biosimilar is issued by the EMA.
Will I experience more side effects with a biosimilar?
No. For the approval of the EMA, biosimilars have to demonstrate studies which prove that the spectrum of effects and side effects match those you would experience if you were prescribed the reference product.
What biosimilar products does STADA have?
STADA was one of the first companies to launch biosimilars in 2008. We already have a portfolio of more biosimilars for a range of indications. These include therapeutic areas like nephrology, osteoporosis, and oncology. STADA will continuously expand its portfolio.