Adalimumab Biosimilar - Step 1 of Puzzle Solved Unamimous Vote from All Committee Members

Amgen has presented and completed step 1 in biosimilar approval process. They are targeting the largest biologics product in the world by sales $12.5B based on biospace.com. Humira is Abbvie flagship and when launch will have the potential to significantly impact companies revenue which is $20B based on the same analysis by biospace

Amgen presented a very complete package today to FDA advisory committee and the data showed that ABP 501 is highly similar to Humira.

While some of the data showed some minor differences in Glycan. The products showed some differences in Mannose, Afucosylation, Sialylation and Galatosesylation which Amgen showed that it had no clinically meaningful differences.

ABP 501= Humira Biosimilar Candidate

The committee was presented with five questions

( 1)  Please discuss whether the evidence from analytical studies supports a demonstration that ABP 501 is highly similar to US-licensed Humira, notwithstanding minor differences in clinically inactive components. 

2.  Please discuss whether the evidence supports a demonstration that there are no clinically meaningful differences between ABP 501 and US-licensed Humira in the studied conditions of use (rheumatoid arthritis (RA) and plaque psoriasis (PsO)). 

3. Please discuss whether the data provides adequate scientific justification to support a demonstration of no clinically meaningful differences between ABP 501 and US licensed Humira for the following additional indications for which US-licensed Humira is licensed: ? Juvenile Idiopathic Arthritis (JIA) in patients 4 years of age and older ? Psoriatic Arthritis (PsA) ? Ankylosing Spondylitis (AS) ? Adult Crohn’s Disease (CD) ? Adult Ulcerative Colitis (UC) 
If not, please state the specific concerns and what additional information would be needed to support such a demonstration.  Please discuss by indication if relevant.  
4. VOTE:  Does the totality of the evidence support licensure of ABP 501 as a biosimilar product to US-licensed Humira for the following indications for which US-licensed Humira is currently licensed and for which Amgen is seeking licensure (RA, JIA in patients 4 years of age and older, PsA, AS, adult CD, adult UC, and PsO)? 

As always I welcome your comments and you can contact me at [email protected] or [email protected]