The scientific differences between traditional pharmaceuticals and biologic products, and the administrative and regulatory procedures governing each of them

Biologic products are a class of therapies whose composition depends on proteins derived from living cells. This is in contrast to traditional pharmaceuticals, which consist essentially of non-living chemical compounds. Among the best-known examples of biologic products are vaccines, insulin, and interferon.16

There are no two identical living cells; and, the environment to which a living cell is exposed can cause changes in the proteins it produces. This can affect the quality, safety, and efficacy of the biosimilar product, compared to the originator-brand product. For example, changes in proteins produced by the living cell may cause antibodies to the biologic product in the body of the patient. For these reasons, the methods of producing biologic products are complex and require advanced technology; and hence, their reproduction or imitation, is considered a matter of the utmost difficulty, especially since the safety, quality and effectiveness and of the biologic product depend basically on its manufacturing process. It is therefore recognised by scientists that biologic products require about two thousand tests to be conducted during the manufacturing process to ensure its QSE. By contrast, traditional pharmaceuticals require only one hundred tests for these purposes.17

Since there are radical differences between traditional pharmaceuticals and biologic products in terms of composition and production process, the reproduction or imitation of biologic products differs significantly from the reproduction of traditional pharmaceuticals, known as generic drugs. Experts in the field are therefore keen on using different terms to distinguish between generic medicines, and imitated biologic products; and have hence called them "biosimilar products".

Notwithstanding the slight differences within the different drug registration authorities worldwide, there is general agreement on the main requirements that must be met for the approving the registration of generic drugs. The most important among these is that the generic drug must be bioequivalent to the originator-brand drug, meaning that the two drugs are essentially equivalent in both their QSE and use indications.18 Thus the generic drug contains the same active ingredient as the originator-brand drug, is identical to it in terms of quality, safety, efficacy and has the same dosage form; thus, making it therapeutically exchangeable with the originator-branded drug. Therefore, in general, drug authorities do not require companies registering generic drugs to carry out clinical trials.

It is important to note that the field of biosimilar drugs, altogether, is in it of itself a new field worldwide. It is difficult to manage this category of therapeuticals, given all the above. It is therefore, that  the majority of the states worldwide, do not have legislations yet to regulate this category of drugs. The EU was the first to issue directives for the registration of biosimilar products in 2005, followed by a number of countries such as Australia, Canada, Malaysia, Pakistan, Saudi Arabia, and others.19  Egypt has not, so far, passed any legislations or adopted any guidelines for the registration of biosimilar products.

In July 2009, the Ministry of Health in Egypt issued decree no.297, "On the Rules and Procedures for the Registration of Biologic products, vaccines, and blood derivatives" to regulate the registration of biologic products. This distinguished between this particular category of drugs and traditional pharmaceutical products.20 However, it has not yet issued any decrees or guidelines for the registration of biosimilar products. According to a source at the Ministry of Health, who spoke to an EIPR researcher in June 2010, registration of biosimilar products was suspended ever since this decree on biologic products passed, pending the issuance of a special decree regulating biosimilar products, in specific.21

Yet the question remains: Since decree no.297 does not deal with biosimilar products, and has suspended their registration onwards, what about biosimilar products which were registered before 2009, like the 'Egyptian Interferon'?