It’s been an exciting start to the new year for the biosimilar industry.
The FDA has released a finalized guidance document for developing biosimilar drugs, which clarifies how drug makers can prove that their drug isn’t meaningfully different from a branded product, also referred to as a reference listed drug. For more information, click here.
And, Pfizer’s Humira biosimilar has hit its efficacy target, having been shown to be just as effective as the AbbVie blockbuster. If FDA approved, Pfizer’s drug will be the second Humira biosimilar to receive the green light, after Amgen’s Amjevita was approved last September. For more information, click here.