Stephen Albainy-Jenei
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Articles by Stephen Albainy-Jenei

| 3 min read
As Congress is considering possible legislation to create an abbreviated pathway for the FDA to approve generic biologic therapies, differences in the R&D expense and product cost, and the potential for both new therapies post-approval and second-generation innovations, have raised questions about how to achieve the proper balance between innovation and competition.

| 3 min read
It appears that no matter who wins the presidential election this November, both Barack Obama and John McCain back expanded use of generic drugs as a way to lower drug costs. According to their advisers, both campaigns have pledged their support to help create a market for generic biotech drugs or biosimilars.

| 2 min read
One way drug companies are compensated for the regulatory burden of seeking FDA approval is the extension of patent terms. One of the eligibility requirements for a patent term extension is that the permission for the commercial marketing or use of the product be the first permitted commercial marketing or use of the product.








