Physician Views: Can an improved formulation of AbbVie's Humira help to stave off the biosimilar threat?

With the biosimilars market having enjoyed notable momentum over the course of 2015, it is perhaps not surprising that AbbVie has been the worst-performing global pharmaceutical company for the year to date.

Sell-side analysts have been debating which factors have weighed most heavily on AbbVie's performance, but it is difficult to look far beyond its dependency on revenues generated by Humira. In the second quarter, Humira accounted for 65 percent of AbbVie's total sales, versus a Big Pharma average of around 23 percent. Furthermore, this 'dependency ratio' has increased from around 45 percent in 2011; a trend that demonstrates both continued strong growth for the Humira franchise and a lack of successful diversification on AbbVie's part. No wonder then management sanctioned the $21-billion acquisition of Pharmacyclics earlier this year.

The sheer size of revenues generated by Humira – poised to exceed $13 billion on a global basis this year – position it as an obvious target for biosimilar developers. Biosimilar versions of other branded biologics that compete with Humira, such as Remicade (Johnson & Johnson/Merck & Co./Mitsubishi Tanabe) and Enbrel (Amgen/Pfizer/Takeda), will also provide an indirect threat to sales of Humira.

AbbVie's biosimilar defence strategy is multi-faceted and in addition to core efforts, which centre around extended IP protection for Humira, includes its recent decision to forward the oral JAK inhibitor ABT-494 into Phase III studies by the end of 2015. Analysts at Jefferies noted this week that "AbbVie management are laser-focused in expediting the development of ABT-494 so that it can be well established in the US prior to the launch of Humira biosimilars."

A shorter-term measure, designed to bolster the Humira franchise ahead of biosimilar entrance, is development of a new Humira formulation, which is designed to reduce injection site pain and reduce injection volume. The new formulation, which has been approved in the EU and is awaiting regulatory clearance in the US, appears to reduce injection site pain by between 50 percent and 80 percent, compared to the older formulation (Spotlight On: Will AbbVie's 'new Humira' strategy protect it against biosimilar competition?).

In a note to investors published earlier this year, analysts at UBS described this reduction as likely to be viewed by physicians as "substantial and clinically relevant." FirstWord's latest Physician Views poll put this assertion to the test and will ask US and EU5-based rheumatologists and gastroenterologists the following questions…

What is your level of concern regarding injection site pain association with Humira injections?
No concern
Slightly concerned
Moderately concerned
Very concerned
Extremely concerned

How often does injection site pain affect your patients' compliance with Humira?
Never
Occasionally
Sometimes
Frequently
Very frequently

How meaningful do you find these clinical trial results for the new Humira formulation? Current Humira: 4.2 +/- 2.72 vs. New Humira: 0.9 +/- 1.44 for injection site pain as measured on a visual analogue scale.
Not meaningful
Slightly meaningful
Moderately meaningful
Very meaningful
Extremely meaningful

When the new Humira formulation becomes available, how will you write a prescription for Humira?
Specify new Humira
Specify current Humira
Don't specify – let pharmacist dispense either
I don't expect to have a choice
I don't prescribe Humira

Assuming biosimilar anti-TNFs become available at a lower cost than the new Humira formulation (and the current Humira formulation is no longer available), how will you write a prescription for Humira?
Specify new Humira
Specify the biosimilar
Don't specify – let pharmacist dispense either
I don't expect to have a choice

You will be able to read the results and analysis next week.

Results and related analysis will be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions.

Note: FirstWord Polls are powered by MedePolls, a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialities and over 100 markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com.

To read more Physician Views articles, click here.