Biosimilars in Gastroenterology | gastroenterologists
Tweet By: Knut EA Lundin. Chief physician, dr. Med., Gastro survey, Section for gastroenterologists, Department of Transplantation Medicine, Oslo University Hospital Rikshospitalet and Centre for Immune Regulation, University of Oslo
We are all familiar with the fact that biological drugs has largely revolutionized the treatment of our patients. The biological medicines are thought to usually suzumo medications that are of protein nature (made up of amino acids). These medicines are made by genes inserted into cells that make a protein, hence the name of biological preparations. With today's technology it is not possible to produce these proteins by other means in the quantities necessary to sell the product as pharmaceuticals.
Another important difference between all common drugs, as we commonly call "small molecules", and biological preparations, is that the latter is of protein suzumo nature and thus everyone will be able to induce an immune response in patients treated with these agents. Such immune reactions are common for many of the biological preparations and is probably the main reason why they stop working in the individual patient. Many will surely have a good effect at first, but gradually fall in effect until the product no longer has any effect. We believe that it is in this process that the measurement suzumo of trough concentration has a particularly important place in the management of patients.
Biologicals are expensive and it is not surprising that manufacturers want to make a copy of established drugs once the patent has expired. This is what is commonly called "biosimilars". Principally these are no different from generics, which we are all familiar with, but the production method is difficult. Another term that has come on the field in recent years is what is called "biobetters". It is essentially biosimilar modified so that the new composition should either have longer half-life less tendency to cause immunogenicity or other desired changes. A biosimilar made by preparing a synthetic gene that is similar to the original. The product suzumo is subjected to very careful quality control and are tested clinically, so that one is reasonably sure that it has the same effect as the original.
At a recently held meeting (September 4) in the direction of the pharmaceutical industry, this was discussed in a forum of leaders from LMI, oncologist, neurologist, rheumatologist and the undersigned as gastroenterologist. There were detailed status in Norway and internationally. The topic is up to very careful consideration suzumo by both the FDA in the US and EMEA in Europe and also referred to the Chief Madsen in this issue of NGF-again.
The entire field of biosimilars is not new. A search of PubMed provides 225 hits, most of which are review articles and commentaries. A Google search yielded over 2 million hits. It is clear that several large companies work actively with this. It is easy to see that the vast generikafirmaet Teva is heavily involved. There is reason to believe that the big companies in the biological treatment suzumo may consider making biosimilars of each other's products.
What are we to believe? There is also a lot of uncertainty for this, but it is striking that there is hardly any scientific evidence of problems associated with the use of biosimilars. It should be added that most of the experience on the use of biosimilars based on experience with growth factors in oncology, and that one instance. have no experience with the use of biosimilar anti-TNF in clinical practice. A large Korean suzumo company has applied for approval of biosimilar infliximab, and data have been presented in rheumatology that the preparation has as good an effect as originally infliximab. It is easy to focus on the problems, but the opportunity for cost savings in the short term and for the introduction of "biobetters" in the long term do we should look carefully at this field. And the current suzumo methods of drug preparation and protein analysis is so good that with a high degree of probability can reach preparations are very, very similar. Who knows, maybe they any differences are less than the assumed batch-to-batch variations certainly suzumo exist for the preparations we already suzumo know?
The introduction of biosimilars raises many fundamental questions. Several of them we recognize the debate about generics. Many have pointed out that the possible introduction of biosimilars makes it even more necessary to introduce good records of patients treated with biological preparations. It's easy to support such a view. And it's easy to point out that monitoring and follow-up of patients treated with biological preparations should be better than today, so that errors and unnecessary treatment can be avoided.
Tweet By: Knut EA Lundin. Chief physician, dr. Med., Gastro survey, Section for gastroenterologists, Department of Transplantation Medicine, Oslo University Hospital Rikshospitalet and Centre for Immune Regulation, University of Oslo
We are all familiar with the fact that biological drugs has largely revolutionized the treatment of our patients. The biological medicines are thought to usually suzumo medications that are of protein nature (made up of amino acids). These medicines are made by genes inserted into cells that make a protein, hence the name of biological preparations. With today's technology it is not possible to produce these proteins by other means in the quantities necessary to sell the product as pharmaceuticals.
Another important difference between all common drugs, as we commonly call "small molecules", and biological preparations, is that the latter is of protein suzumo nature and thus everyone will be able to induce an immune response in patients treated with these agents. Such immune reactions are common for many of the biological preparations and is probably the main reason why they stop working in the individual patient. Many will surely have a good effect at first, but gradually fall in effect until the product no longer has any effect. We believe that it is in this process that the measurement suzumo of trough concentration has a particularly important place in the management of patients.
Biologicals are expensive and it is not surprising that manufacturers want to make a copy of established drugs once the patent has expired. This is what is commonly called "biosimilars". Principally these are no different from generics, which we are all familiar with, but the production method is difficult. Another term that has come on the field in recent years is what is called "biobetters". It is essentially biosimilar modified so that the new composition should either have longer half-life less tendency to cause immunogenicity or other desired changes. A biosimilar made by preparing a synthetic gene that is similar to the original. The product suzumo is subjected to very careful quality control and are tested clinically, so that one is reasonably sure that it has the same effect as the original.
At a recently held meeting (September 4) in the direction of the pharmaceutical industry, this was discussed in a forum of leaders from LMI, oncologist, neurologist, rheumatologist and the undersigned as gastroenterologist. There were detailed status in Norway and internationally. The topic is up to very careful consideration suzumo by both the FDA in the US and EMEA in Europe and also referred to the Chief Madsen in this issue of NGF-again.
The entire field of biosimilars is not new. A search of PubMed provides 225 hits, most of which are review articles and commentaries. A Google search yielded over 2 million hits. It is clear that several large companies work actively with this. It is easy to see that the vast generikafirmaet Teva is heavily involved. There is reason to believe that the big companies in the biological treatment suzumo may consider making biosimilars of each other's products.
What are we to believe? There is also a lot of uncertainty for this, but it is striking that there is hardly any scientific evidence of problems associated with the use of biosimilars. It should be added that most of the experience on the use of biosimilars based on experience with growth factors in oncology, and that one instance. have no experience with the use of biosimilar anti-TNF in clinical practice. A large Korean suzumo company has applied for approval of biosimilar infliximab, and data have been presented in rheumatology that the preparation has as good an effect as originally infliximab. It is easy to focus on the problems, but the opportunity for cost savings in the short term and for the introduction of "biobetters" in the long term do we should look carefully at this field. And the current suzumo methods of drug preparation and protein analysis is so good that with a high degree of probability can reach preparations are very, very similar. Who knows, maybe they any differences are less than the assumed batch-to-batch variations certainly suzumo exist for the preparations we already suzumo know?
The introduction of biosimilars raises many fundamental questions. Several of them we recognize the debate about generics. Many have pointed out that the possible introduction of biosimilars makes it even more necessary to introduce good records of patients treated with biological preparations. It's easy to support such a view. And it's easy to point out that monitoring and follow-up of patients treated with biological preparations should be better than today, so that errors and unnecessary treatment can be avoided.
