Contributions
Abstract: 28
Type: Hot Topic
Abstract Category: N/A
Multiple sclerosis (MS) care is expensive, and drugs account for a substantial and increasing proportion of the costs. The patents for several disease modifying medications for MS have expired or soon will, allowing for the introduction of follow-on products with the hope that they will provide cost savings. Several types of follow-on products are distinguished by regulatory bodies, including products proposed to be equivalent to small molecule medications (generics, e.g. fingolimod, dimethyl fumarate), biological products (biosimilars, e.g. monoclonal antibodies such as rituximab), and complex non-biologic products (e.g. glatiramer acetate). A follow-on product is not required to be identical to the reference (original brand) product but comparable or highly similar with no clinically meaningful differences in purity, safety, and potency. The development process for follow-on products is designed to show chemical, biophysical, and pharmacological equivalence to the original brand product both in vitro and in vivo. The regulatory considerations for the three categories of follow-on three follow-on products share some common features but also have several important differences, including the design of in human studies required. Success in the development of a follow-on product depends on the ability to offer an equivalent medication at reduced cost, and represents somewhat of a compromise. Too stringent requirements and types of evidence to demonstrate equivalence create a disincentive to pharmaceutical companies to develop follow-on products due to high cost. Conversely, too relaxed requirements may jeopardize safety and efficacy and, as a result, confidence of patients and prescribers in the follow-on product. As follow-on products emerge, there will be increasing pressure from payors to utilize follow-on products in lieu of more expensive original brand MS disease modifying medications. Therefore, it is important for clinicians to be familiar with the associated regulatory and clinical considerations.
Disclosure: Dr. Jeffrey Cohen reports personal fees for consulting from Adamas, Celgene, Convelo, EMD Serono, Novartis, and PendoPharm; speaking for Mylan; and serving as Co-Editor of Mult Scler J - ETC.
Abstract: 28
Type: Hot Topic
Abstract Category: N/A
Multiple sclerosis (MS) care is expensive, and drugs account for a substantial and increasing proportion of the costs. The patents for several disease modifying medications for MS have expired or soon will, allowing for the introduction of follow-on products with the hope that they will provide cost savings. Several types of follow-on products are distinguished by regulatory bodies, including products proposed to be equivalent to small molecule medications (generics, e.g. fingolimod, dimethyl fumarate), biological products (biosimilars, e.g. monoclonal antibodies such as rituximab), and complex non-biologic products (e.g. glatiramer acetate). A follow-on product is not required to be identical to the reference (original brand) product but comparable or highly similar with no clinically meaningful differences in purity, safety, and potency. The development process for follow-on products is designed to show chemical, biophysical, and pharmacological equivalence to the original brand product both in vitro and in vivo. The regulatory considerations for the three categories of follow-on three follow-on products share some common features but also have several important differences, including the design of in human studies required. Success in the development of a follow-on product depends on the ability to offer an equivalent medication at reduced cost, and represents somewhat of a compromise. Too stringent requirements and types of evidence to demonstrate equivalence create a disincentive to pharmaceutical companies to develop follow-on products due to high cost. Conversely, too relaxed requirements may jeopardize safety and efficacy and, as a result, confidence of patients and prescribers in the follow-on product. As follow-on products emerge, there will be increasing pressure from payors to utilize follow-on products in lieu of more expensive original brand MS disease modifying medications. Therefore, it is important for clinicians to be familiar with the associated regulatory and clinical considerations.
Disclosure: Dr. Jeffrey Cohen reports personal fees for consulting from Adamas, Celgene, Convelo, EMD Serono, Novartis, and PendoPharm; speaking for Mylan; and serving as Co-Editor of Mult Scler J - ETC.