One of the major hurdles for biosimilars manufacturers is meeting the rigorous demands of regulators who are coming to terms with the challenges that the new industry provides.
In the European Union, for example, a legal framework for approving biosimilars was oiriginally established in 2003, which meant that that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not on the basis of decision by individual nations. Omnitrope (somatropin) was the first product approved in the EU as a biosimilar in 2006 and, to date, the EMA has approved 21 biosimilars for use in the EU within the classes of human growth hormone, granulocyte colony-stimulating factor, erythtropoesis stimulating agent, insulin and tumour necrosis factor (TNF)-inhibitor. Two approvals were subsequently withdrawn, leaving 19 biosimilars approved for use in Europe. In the United States, law-makers have been taking similar action and a raft of measures were enshrined in the Patient Protection and Affordable Care Act (Affordable Care Act), which was signed into law by President Obama in 2010. The Act created regulations governing biosimilars that are proved are be ‘interchangeable’ with a biological product already licensed for use by the FDA on the basis that both treatments have the same effect.
Under the Act, a biological product may be demonstrated to be biosimilar only if research data shows that, among other things, the product is ‘highly similar’ to an already-approved biological product. Only minor differences in clinically inactive components are allowable in biosimilar products under the terms of the legislation. Fail to meet those stipulations and it will not be regarded as a biosimilar. Under the law, once approved an interchangeable biological product may be substituted for the original drug by a pharmacist without going back to the doctor who issued the original prescription. The FDA says that it requires licensed biosimilar products to meet the agency’s rigorous standards of safety and efficacy, pointing out ‘that means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product.’
Commissioner Margaret A. Hamburg, M.D, can see great benefits in new sector as long as the regulations are correctly administered. She said: “Biosimilars will provide access to important therapies for patients who need them. Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.” “Biosimilars will provide access to important therapies for patients who need them. Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”
Margaret A. Hamburg, M.D, Commissioner
