Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...

Federal regulators are trying to make it easier to develop cheaper alternatives to powerful drugs that many Americans depend on to treat autoimmune diseases or cancers. The Food and Drug ...

Biologics are complex medications produced through biological processes or from living organisms such as proteins and genes. Biosimilars are what they sound like — similar to, but not the same as, an ...

Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...

The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic drugs made with or isolated from living organisms such as ...

After raising nearly $90 million in its recent public offering, Vancouver-based Absci is advancing toward clinical trials for what would be its first biologic drug candidate. Absci uses its database ...

The Biologics Price Competition and Innovation Act of (BPCI Act) of 2009 granted responsibility to the FDA for review and approval of a new class of pharmaceuticals referred to as “Biosimilars.” (1) ...

WASHINGTON - The Food and Drug Administration announced Wednesday that it plans to streamline the approval process for cheaper, "biosimilar" alternatives to biologic drugs in an effort to reduce ...

SEATTLE--(BUSINESS WIRE)--Lumen Bioscience, a clinical-stage biopharmaceutical company developing biologic drugs for highly prevalent diseases, today announced the closing of a $16 million Series B ...

The Food and Drug Administration said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive ...

Hidradenitis suppurativa is managed with biologics like adalimumab and secukinumab, approved for moderate-to-severe cases. Adalimumab, a TNF-α inhibitor, was FDA-approved in 2015, while secukinumab, ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...