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What are Generics?
One of STADA's important business areas is the production and sales of inexpensive medicines that are generally known as generics. But what does this term actually mean?
Generics are pharmaceutical products that contain the exact active pharmaceutical ingredient as the original patented product of the initial supplier. Despite their high quality, generics are substantially cheaper.
How can there be such a substantial difference in price?
Pharmaceutical companies patent the drugs that arise from their own research and this allows them to have a monopoly in the sales of a product for many years. This means that these companies do not have to worry about competitors when setting prices so they can charge high prices. But once an initial supplier's patent, which can last for up to 25 years, has expired, other manufacturers of medicines like STADA can also produce these long-standing pharmaceutical products and sell them at significantly lower prices. These medicines are called generics.
Who benefits from STADA's low prices?
Many of the generics we produce can be purchased from a pharmacy without a prescription. In these cases, patients benefit directly from the significant difference in prices. Try to compare the prices for yourself. You would reap the benefits of directly asking your pharmacist for the STADA alternatives available.
STADA's prescription generics, which only a doctor can prescribe, also provide substantial cost savings in the public health care system. And this of course helps everyone since we all want our health care system to remain affordable and our health insurance payments stable. By the way: today more than 70% of prescriptions in Germany are for generics!
Are there differences in quality?
All pharmaceutical products approved for sale in Germany are subject to the same strict inspections and quality controlling by governmental regulatory authorities as with original products. A generic medicine must also meet every single requirement without a single exception. The effectiveness and safety of a generic product is equal to that of the original patented medicine. We aspire to the highest quality requirements. Experience and diligence in development and approvals as well as competency in production guarantee doctors and patients safe products and therapies.
Always low prices and easy to recognize: STADA generics!
Our generics are not only cheap, they are also very easy to recognize thanks to their packaging. See if you can pick out the STADA logo with the red corner at your local pharmacy. The name of our generics is almost always made up of the name of the active ingredient and the name of the manufacturer of the product.
What are Biosimilars?
Biosimilars are copies of biotechnologically produced drugs, so-called biopharmaceuticals. These are active substances obtained from living cells of plants or animals. Biopharmaceuticals now play an important role in the treatment of many serious diseases such as osteoporosis, arthritis and cancer. Compared to generic drugs, i.e. copies of chemically produced drugs, biosimilars require considerably more time and effort for the development as well as control of the manufacturing process and require a significantly bigger amount of data that must be submitted for approval. One reason for this is that the structure of biotechnological drugs is much more complex than that of chemically produced drugs. On the other hand, the complex production process within living organisms leads to natural fluctuations also present in the original medicine. This also means that biosimilars are never identical copies of the original preparations. However, the differences must be kept within strict limits to ensure comparability of the biosimilar with its reference product. For companies producing biosimilars, these narrow limits result in high investments – whether for development, clinical studies, quality assurance in high-tech production processes or approval. With this final step the respective competent authority confirms that the biosimilar is equivalent to the original product in terms of efficacy, quality and safety.
A biosimilar medicine is developed to be highly similar to an existing biological medicine (“reference medicine”), meaning that they are essentially the same.
Biosimilars are approximately 20 – 25 percent cheaper than the original preparations.1
(1 Pro Generika e.V.)
Myths and Facts
MYTH: Biosimilars as well as generics can be offered at a very low price.
FACT: Biosimilars have to be produced in a complex process and tested extensively. Although they can therefore be cheaper than the reference drug, the savings are only around 20-25 percent and not around 65 percent, as is the case with generics.
MYTH: With the biosimilars currently available, the treatment spectrum has already been exhausted.
FACT: The spectrum of biosimilars will expand significantly. Several projects are currently in the approval process, including biosimilars for Adalimumab, Trastuzumab and Rituximab. Many other biosimilars for further indications are in an advanced development phase.
MYTH: Biosimilars are of lower quality than the reference drug.
FACT: Manufacturers of biosimilars are required to demonstrate quality, safety and efficacy according to the same standards as for the approval of the reference drug. Thus the quality is the same.
MYTH: Biosimilars are not likely not relieve the health care system economically, as they are hardly offered at a lower price than the reference preparations.
FACT: Due to the high price level in the field of biopharmaceuticals, even rather small percentage discounts lead to absolutely considerable savings for the healthcare system.
MYTH: Side effects are more frequent with biosimilars.
FACT: Biosimilars must show in the approval studies that both the spectrum of effects and the side effects is comparable to that of the reference drug.
MYTH: The introduction of biosimilars carries the risk of new adverse drug reactions for a long-established active substance.
FACT: Since the approval of the first biosimilars, no new adverse drug reactions have been reported for these active substances, nor did a biosimilar have its marketing authorization withdrawn for safety reasons.
Are biosimilars cheaper than original products?
When the original biopharmaceutical producer's patent expires, the medicine can also be produced and sold by other suppliers. This leads to more competition and decreased costs.
The price difference between a biosimilar and the original product is, however, smaller than that between a generic and an original drug. This is because biosimilars are produced using a highly complex biotechnological process and the manufacturers must make heavy investments in clinical studies, challenging production processes and the approval of European approval authorities.
Biosimilars, nevertheless, represent a clear price advantage as compared to the original products. According to current statistics, savings range from approx. 20 to 25% (source: Pro Generika e.V.), which represents a significant relief for health care systems.
Are biosimilars equivalent to original products?
Biosimilars are tested by the European Medicines Agency (EMA) for quality, effectiveness and safety before they can be marketed in Germany and other European countries. Once a medicine is approved, the European Commission then confirms that the biosimilar is equivalent to the original product in terms of effectiveness, quality and safety. After approval, biosimilars are subject to the same strict requirements and ongoing monitoring of authorities as the products of the original producer.
What biosimilar products does STADA have?
STADA already has long-standing experience in this relatively young area of medicine. STADA introduced a biosimilar for the therapeutic areas of nephrology and oncology as early as 2008. In August 2014, another biosimilar was introduced for the indication of chemotherapy-induced neutropenia.
Furthermore, there has been a cooperation with Gedeon Richter since 2011 which includes, among other things, a biosimilar for the area of oncology used for non-Hodgkin lymphoma, for example, or for the treatment of autoimmune diseases such as rheumatoid arthritis. Pending successful development, this product is expected to launch in the year 2018.
Moreover, we expanded our biosimilar portfolio in 2014 by in-licensing a biosimilar for the indication of osteoporosis. From today's perspective, we expect to launch this product in 2019 pending successful development and the expiration of patent protection. We are also continuously reviewing options for in-licensing biosimilars in various indication areas with the goal of remaining capable of expanding our biosimilar portfolio in future.
Furthermore, in 2015, a license and sales agreement with Gedeon Richter regarding a biosimilar for the treatment of neutropenia, which is to be launched to the market in 2017 upon patent expiry, was signed. This illness is a common side effect of cytotoxic chemotherapies and results from a low amount of certain white blood cells.