Health Boards
Sat-21-11-2015, 12:49 PM
(Fri-20-11-2015, 23:21 PM)mataribot Wrote: Let's cut the poop. Biosimilars are NOT similar or even a copy of the patent drug. They are just another TNF that didn't have to go through all the requirements the patent drug did.
Sorry Matari but I disagree.
Quote:
A similar biological or 'biosimilar' medicine is a biological medicine that is similar to another biological medicine that has already been authorised for use.
Biosimilars can only be authorised for use once the period of data exclusivity on the original 'reference' biological medicine has expired. In general, this means that the biological reference medicine must have been authorised for at least 10 years before a similar biological medicine can be made available by another company.
Role of the European Medicines Agency:
The Agency is responsible for assessing applications from companies to market biological medicines for use in the European Union (EU), including biosimilar medicines.
Requirements for authorisation of biosimilar medicines:
For biosimilar medicines, the company needs to carry out studies to show that the medicine:
#1 Is similar to the reference medicine.
#2 Does not have any meaningful differences from the reference medicine in terms of quality, safety or efficacy.
As information on the reference medicine is already available, the amount of information on safety and efficacy needed to recommend a biosimilar for authorisation is usually less than the amount needed to authorise an original biological medicine.
As with all medicines, the Agency continues to monitor the safety of biosimilar medicines once they are on the market.
How are biosimilar medicines evaluated in the EU?
Because the reference medicine has been authorised in the EU for several years and its clinical benefit is established, some studies carried out with the reference medicine may not need to be reproduced. Since 2003, a new EU pathway for approving biosimilar medicines has been in place. The main part of the evaluation is a comparison of the biosimilar with its reference medicine to show that there are no significant differences between them.
The relevant regulatory authority applies stringent criteria in their evaluation of the studies comparing the quality, safety and effectiveness of the two medicines. The studies on quality include comprehensive comparisons of the structure and biological activity of their active substances, while the studies on safety and effectiveness should show that there are no significant differences in their benefits and risks, including the risk of immune reactions.
Biosimilar medicines are manufactured following the same standards as for other medicines, and regulatory authorities perform periodic inspections of the manufacturing sites.
How is the safety of biosimilar medicines monitored?
As for all medicines, the safety of biosimilar medicines is continuously monitored after authorisation. Each company is required to set up a system to monitor side effects reported with its medicines. Patients can also report suspected side effects themselves. The regulatory authorities evaluate the safety data that is captured as well as the company’s safety monitoring system. When signals of a safety concern arise, regulatory authorities investigate and take action as appropriate.
Source: European Medicines Agency
Yes the original would have gone through more, but that is because it would have been a completely new drug and had to go through more rigorous testing. A Similar however is just a copy of the original and the testing isn't so costly to the manufacturer as most of the information on the product is out there and it has been used for ten years.
