Biologicals are drugs consisting of natural proteins, such as antibodies and cytokines, or fragments of proteins or synthetic peptides. In the Netherlands, the term is mainly confined to artificial peptides very specific signaling proteins (such as receptors or cytokines) off and as disease processes (such as rheumatoid arthritis, psoriasis, inflammatory bowel disease, cancer, macular degeneration) works. The Dutch Medicines Evaluation Board (MEB) as a definition: "A biological medicine is a medicine whose active substance is produced by or derived from a living organism instance, insulin can be produced by a living organism (such as a bacterium or. a yeast) which has been provided with a gene that allows the production of insulin. "
Development
When these proteins involves large, complex molecules that are susceptible to degradation in the gastrointestinal tract. These agents are, therefore, given as a subcutaneous, intramuscular, or intravenous injection. They can be extracted, or may be produced via recombinant DNA technology from an animal tissue. The names of many biologicals ends -ab-. This is of antibody (Eng.), In those cases it usually involves monoclonal antibodies.
Biologicals may be developed by the ever-increasing knowledge of the pathophysiology of various diseases; in particular, the processes in the field of immunology.
Use in disorders
The number of disorders for which a biological can be developed is inexhaustible; knowledge of the immunological processes that lies at the basis of various diseases, is increasing, and thus the number of possible targets against which one can develop a biological. The same goes for the "ordinary" (chemical) drugs. However, a major difference with the chemicals, the price of biologicals; these are much more expensive. Often this involves (tens of) thousands of dollars per year. Large, more recent breakthroughs were particularly trastuzumab (Herceptin ®) and the means for rheumatoid arthritis, psoriasis and Crohn's disease. The former because it means 20-30% of women with HER2-positive breast cancer (poor prognosis) now perspective could offer, and other resources because large groups of patients with this new alternatives were available to them, especially for the more serious cases .
Preferential Policy in Netherlands
In the Netherlands the discussion going, or the preferential policy of health insurance can be extended to the biological. The court in The Hague said on June 1, 2011 is already out that as regards the WGP (Pharmaceuticals Price Act) may be assumed pharmaceutical interchangeability and not of therapeutic interchangeability. CVZ released on September 29, 2011 an affirmative report. This happened after consultation of the MEB. Minister Schippers presented on December 7, 2010 in response to parliamentary questions: "For biological medicinal preference policy can be implemented." The registration requirements for "generic biologicals, called biosimilars, are significantly more stringent than for 'generic chemical drugs.
EMA requires, in addition to demonstrating a similar pharmacokinetic profile with the biosimilar medicines include comparative studies are conducted.
Therapeutic preference policy in the Netherlands
Therapeutic preference policy is when a health care provider within a group of similar active substances, one substance designated for reimbursement.
Minister Klink of Health wrote in his 2010 budget: "Moreover, I do welcome the principle of therapeutic preference policy. Here I will in the coming period, further investigation into them carried out so that it can possibly be given from 2012 figure. To allow therapeutic preference policy is moreover necessary to amend the Insurance Decree. "
The court in Arnhem pointed at May 24, 2011 judgment on appeal, that the autonomy of the prescribing physician in a case confirmed. These were the interchangeability of adalimumab and infliximab.
Summary
The table below attempts to give an overview of the most important and most recent approvals (in the US) of biologicals as medicine. Biologicals approved by the FDA in the US, also usually get in the foreseeable future in Europe through the centralized procedure by the EMEA registration. A European record means that it is allowed on the Dutch and Belgian market. It can also prevent an agent previously authorized in Europe than in the US For the European registrations JAMA.
Development
When these proteins involves large, complex molecules that are susceptible to degradation in the gastrointestinal tract. These agents are, therefore, given as a subcutaneous, intramuscular, or intravenous injection. They can be extracted, or may be produced via recombinant DNA technology from an animal tissue. The names of many biologicals ends -ab-. This is of antibody (Eng.), In those cases it usually involves monoclonal antibodies.
Biologicals may be developed by the ever-increasing knowledge of the pathophysiology of various diseases; in particular, the processes in the field of immunology.
Use in disorders
The number of disorders for which a biological can be developed is inexhaustible; knowledge of the immunological processes that lies at the basis of various diseases, is increasing, and thus the number of possible targets against which one can develop a biological. The same goes for the "ordinary" (chemical) drugs. However, a major difference with the chemicals, the price of biologicals; these are much more expensive. Often this involves (tens of) thousands of dollars per year. Large, more recent breakthroughs were particularly trastuzumab (Herceptin ®) and the means for rheumatoid arthritis, psoriasis and Crohn's disease. The former because it means 20-30% of women with HER2-positive breast cancer (poor prognosis) now perspective could offer, and other resources because large groups of patients with this new alternatives were available to them, especially for the more serious cases .
Preferential Policy in Netherlands
In the Netherlands the discussion going, or the preferential policy of health insurance can be extended to the biological. The court in The Hague said on June 1, 2011 is already out that as regards the WGP (Pharmaceuticals Price Act) may be assumed pharmaceutical interchangeability and not of therapeutic interchangeability. CVZ released on September 29, 2011 an affirmative report. This happened after consultation of the MEB. Minister Schippers presented on December 7, 2010 in response to parliamentary questions: "For biological medicinal preference policy can be implemented." The registration requirements for "generic biologicals, called biosimilars, are significantly more stringent than for 'generic chemical drugs.
EMA requires, in addition to demonstrating a similar pharmacokinetic profile with the biosimilar medicines include comparative studies are conducted.
Therapeutic preference policy in the Netherlands
Therapeutic preference policy is when a health care provider within a group of similar active substances, one substance designated for reimbursement.
Minister Klink of Health wrote in his 2010 budget: "Moreover, I do welcome the principle of therapeutic preference policy. Here I will in the coming period, further investigation into them carried out so that it can possibly be given from 2012 figure. To allow therapeutic preference policy is moreover necessary to amend the Insurance Decree. "
The court in Arnhem pointed at May 24, 2011 judgment on appeal, that the autonomy of the prescribing physician in a case confirmed. These were the interchangeability of adalimumab and infliximab.
Summary
The table below attempts to give an overview of the most important and most recent approvals (in the US) of biologicals as medicine. Biologicals approved by the FDA in the US, also usually get in the foreseeable future in Europe through the centralized procedure by the EMEA registration. A European record means that it is allowed on the Dutch and Belgian market. It can also prevent an agent previously authorized in Europe than in the US For the European registrations JAMA.