Frequently Asked Questions
We have collected the most important and frequently asked question about our business. Please note that generics are subject to different legal definitions in different countries. The definition of generics used in this context does not make reference to any particular legal definition.For further questions, please contact our Global department
|Generics in General||Comparability and Safety||Recombinant Technologies and Biosimilars|
What are biosimilars?
Biosimilars – an abbreviation of Similar Biological Medicinal Product – are new versions of existing biopharmaceuticals (mostly proteins) whose patents have expired. They are produced using the same core genetic material and are approved on the basis that they are comparable to the reference product in terms of safety and efficacy. They are large, complex molecules produced by living organisms, which are highly sensitive to manufacturing changes. In contrast, generics are small chemical pharmaceuticals and produced by chemical synthesis, usually a very stable process. Biosimilar is an official term used by the European medical authorities; the U.S. terminology is follow-on protein products (FOPP).
The production of biosimilars presents major process challenges in terms of their manufacture, purity, formulation and storage. It is necessary to demonstrate that the biosimilar product’s interaction with the receptor is comparable to that of the reference product. As such, the biological similarity of the two is determined not only in the laboratory, but also in clinical studies, a step not needed for classic generics.
How important are biosimilars?
In 2010, the patents of many major biopharmaceuticals will start to expire, paving the way for biosimilar competition. It is estimated that by 2010, some 50% of newly approved medicines will be biopharmaceuticals that later on will eventually face patent expiry. In other words, biosimilars are a key future market for companies like Sandoz.
What are biopharmaceuticals?
Biopharmaceuticals (or biologics) are medicinal substances produced in genetically modified organisms by means of biotechnology. In contrast to “classic” chemically synthesized substances, biotechnologically produced substances are large, complex proteins with molecular weights between 5 000 and 145 000 daltons, in some cases as high as 500 000 daltons. By comparison, aspirin has a molecular weight of 180 daltons. Today, biopharmaceuticals such as recombinant insulin, interferon or erythropoietin are indispensable in practice. Indeed, in many fields there are no real therapeutic alternatives.
What is biotechnology?
Biotechnology is the use of the cell’s biochemistry to produce therapeutically useful proteins in significant industrial quantities (scales). Cells from or derived from living organisms are used to produce large and complex protein molecules, often by using recombinant technologies.
What are recombinant technologies?
Biotechnology can be used to mass-produce essential human proteins, for example insulin. Prior to that, the gene producing the particular protein has to be discovered. In a second step, the gene has to be inserted (recombine it) into rapidly dividing cells, typically a bacterium of some kind. The cells can then produce the relevant protein, which is extracted and purified for therapeutic use.
What is the difference between biosimilars and generics?
To put it simply: Biosimilars are large, complex molecules (mostly proteins) produced by living organisms, which are highly sensitive to manufacturing changes; generics are small molecules, produced by chemical synthesis, which are usually very stable.
What are the regulatory terms in the field of biosimilars and biopharmaceuticals?
Biosimilars is the accepted regulatory term in the EU; follow-on-protein products (FOPPs) is the equivalent term in the U.S. as biologics, or biological medicines, is another term for biopharmaceuticals. Biogenerics is not an accepted regulatory term.
Are biosimilars the same as the reference product?
Biosimilars are not chemically identical to the reference product in the same way as generics – they are produced by living organisms, not by chemical synthesis. However, they are products that have been demonstrated to the satisfaction of the regulator to be comparable to the reference product in terms of quality, safety and efficacy.
Is the regulation procedure similar?
Biosimilars are approved in the EU through an abbreviated registration process based on strict guidelines. Prior to this, they undergo an extensive development process, including pre-clinical and clinical trials to confirm both safety and efficacy. These trials are not required for traditional generics.
What are the differences in the development process for biosimilars and generics?
There are major differences, with unique requirements for biosimilars at all three stages (technical, non-clinical and clinical development). These include design specification, special analytics, extensive pre-clinical work and more clinical trial requirements.
Do biosimilars take longer to be developed?
The difference is currently considerable. Biosimilars can take more than twice as long to be developed as generics.
What is the legislative position?
A legislative pathway already exists in the EU – thanks largely to the pioneering efforts of Sandoz, which received the first ever approval for a biosimilar medicine in 2006 (Omnitrope®, an approved version of somatropin, or human growth hormone). Omnitrope® has also been approved in the U.S., but under an existing procedure. A specific U.S. legislative pathway for biosimilars, similar to the European one, is still being defined
How many biosimilars has Sandoz already on the market?
Since the approval of Omnitrope® in 2006, Sandoz has received EU approval for a second product – Binocrit®, the first complex biosimilar on the market. This is a version of epoetin alfa, a medicine which is already marketed under various brand names to regulate the formation of red blood cells. More than 250 000 patients in Europe are estimated to be treated with epoetin alfa and similar medicines.
How are biosimilars sold / prescribed?
Biosimilars are obtainable mainly the same way as other prescription medicines. However, one major difference between biosimilars and generics is that pharmacists do not have the right to “substitute” biosimilars for reference biopharmaceuticals prescribed by a physician. In other words, the pharmacist has to provide the product prescribed by the physician.
Are there different types of biosimilars?
There are potentially as many types of biosimilars as there are types of reference biopharmaceuticals. These range from relatively simple proteins like the hormone insulin to highly complex molecules such as monoclonal antibodies (mAbs) and fusion proteins.
What are monoclonal antibodies?
Monoclonal antibodies are antibodies that are identical to each other because they are produced by identical clones of a single parent cell of a certain immune cell type. Antibodies bind to specific protein molecules and therefore are invaluable in research, medicine, and industry. They can be produced in commercial quantities using biotechnology methods. Scientists today are able to produce antibodies that are fully human.
Why are they monoclonal antibodies important as medicines?
Monoclonal antibodies have particular relevance in treating cancer, but also other diseases where a specific protein is targeted. They enable the development of target-specific medicines through thorough binding to the targeted structure. The antibody produced through genetic recombination can be manipulated to incorporate a cell toxin, i.e. a radioisotope. This can then be administered to a cancer patient for example, killing the cancer cells to which the antibodies are attached, but leaving others intact.
What are fusion proteins?
Naturally occurring fusion proteins, also known as chimeric proteins, are known to play a role in the development of certain types of cancer. Artificial fusion proteins are created after the joining of two or more genes (recombinant DNA technology) that originally coding for separate proteins.