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Market Access Strategic Execution Consultant

Biosimilars

Collaborations Among Stakeholders

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Collaborations Among Stakeholders

How can us market access professionals (strategists, writers, editors, and everyone else) possibly do our work if we’re not curious enough to seek out our customers’ voice?

In market access, we often treat our asset as our own child and customers’ needs as a stepchild. This backfires on the business as the stepchild always turns out to be the Cinderella of the story.

Isn’t the goal of manufacturers, payers, and providers ultimately the same? To keep patients healthy enough so they stay out of the health care system? It’s just that the market demands each stakeholder to address this call in a different way.

AMCP’s Partnership Forum is a platform where these stakeholders collaborate on tactics and strategies to drive efficiencies and outcomes.

Tapestry Networks is another platform that brings together such stakeholders.

I wonder if there are other such collaborative platforms out there.

Today is the First Day of Your Product’s Life Cycle

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Today is the First Day of Your Product's Life Cycle

What a phenomenal shape the circle is.

Where does it begin? Now, where does it end.

Is it possible that the circle could’ve started at any another point?

Yesterday ended last night. Today is the first day of the rest of your product’s life.

70% of launches fail. There’s evidence to suggest that the first year sets the trajectory for the rest of the product’s life cycle.

Cycle = circle.

Even if your drug has already launched, do you get another chance to begin?

How you got here is not how you will get there. 

The asset inventory is what it is. It takes months-years to generate new evidence. What will you do in the meantime? Your product already has what it needs to penetrate the market in a way that no other product can–if you allow it.

Take a page from Zig Ziglar’s playbook: If you give them enough of what they want, they will give you everything you want.

Your Customers Should Feel Heard

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Your Customers Should Feel Heard

Everyone has a problem.

Believing that your customers have no problems is just as true as believing that everyone posting smiling photos on Instagram has no problems.

What’s the problem of your customers? What keeps them up at night? What makes it dreadful for them to come back to work the next day? Why are they right to think this way?

The sequel to this would be: How can you show up to delight them? But let’s not get ahead of ourselves. 

Customers feeling like they’re heard is in itself a TREMENDOUS stride forward.

Nurture trust. Nurture relationship.

If your neighbor knocked at your door with freshly baked cherry pie, would you accept it? What if a stranger did the same thing: would you accept it?

Innovation and outcomes data can ward off the biosimilar threat

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Biologics, for the longest time, had been enjoying freedom from generic erosion. Now, biosimilars are an impending threat to these biologics.

FDA approval of a biosimilar is only the first hit. Upon FDA approval, payers are already using publicly available data and approved labeling to see how they can leverage biosimilars in their contracting strategies.

Even so, the LAUNCH of the biosimilars is what really puts a dent in the revenue. Biosimilar launch is an important milestone, considering only 7 of the 20 currently FDA approved biosimilars have launched into the market (see Figure 1 below for my summary of approved and marketed biosimilars in the US). Threat of patent litigation is the biggest hurdle to overcome for biosimilars before they can launch into the market.

Figure 1

Despite biosimilar launch, the reference product might be able to retain a reasonable market share—UNLESS, the biosimilar is designated as interchangeable by the FDA. The FDA recently issued the final guidance on interchangeability designation last month. I believe that biosimilars deemed as interchangeable by the FDA can cause a lethal blow to the reference product (in terms of market access and subsequent market share), because that’s when a biosimilar can truly behave like a generic drug and cause that “generic erosion” that we all know about.

So, what are the options for manufacturers of the reference products? 

A) Take cover, you’re in for a hit
B) Start a campaign to downplay the importance of biosimilars
C) Innovate to bring a meaningful change to the market

When in doubt, go with ‘C.’ The adage didn’t always serve me well in pharmacy school, but that IS the correct answer here (former commissioner of the FDA, Scott Gottlieb, would agree with me).

The biosimilar threat is real. However, having a good pulse on the market will enable a sound strategy to retain—and perhaps even grow—the market share of the reference product.

According to an insightful analysis by Rand, Amgen has been able to successfully put up a fight against not just 1, not 2, not 3, but 4 biosimilars in the market through innovation. 

Genentech’s Herceptin (trastuzumab) is up for a similar fight against an army of 5 biosimilars (already approved, though yet to launch). Innovation seems to be the name of the game for Genentech as well: interestingly, in February 2019, FDA approved Genentech’s Herceptin HYLECTA, a subcutaneous version of the intravenous Herceptin. If Genentech can successfully serve this innovation up to payers and organized customers, such as IDNs, with the proper outcomes data, I think Genentech will be just fine.

Innovation is certainly a steep climb, and Amgen and Genentech are clearly taking the high road to accept this challenge.

This just goes to show that there is ALWAYS room for improvement. Furthermore, those who are agents of change that continue to improve, take the cake. In the famous words of Steve Jobs, “Innovation distinguishes between a leader and a follower.” 

It’s time to make big strides and turn heads. Ready. Set. Access.

Krishna Patel, PharmD
Market Access Strategy and Execution Consultant
info@sojusllc.com
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