From The Editor | October 31, 2018

Mylan's Pegfilgrastim Journey: Retracing Its Steps Towards Fulphila's Launch

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By Anna Rose Welch, Editor, Biosimilar Development
Follow Me On Twitter @AnnaRoseWelch

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During the past two years, we grew accustomed to reading headlines about how challenging it was for biosimilar companies to develop and earn regulatory approval for pegfilgrastim biosimilars. In 2017 alone, Coherus, Mylan/Biocon, and Sandoz received complete response letters from the FDA, and both Sandoz and Mylan/Biocon withdrew their applications from the European Medicines Agency (EMA) due to GMP concerns.

While 2016 and 2017 made a biosimilar pegfilgrastim approval seem mythical, 2018 so far has been a cause for celebration. In recent weeks, two pure play biosimilar companies, Cinfa and Coherus (unicorns!), along with Sandoz, Accord Healthcare, and Mylan/Biocon announced positive CHMP opinion for their respective pegfilgrastim biosimilars. In addition to an EMA nod, Mylan became the first to win an FDA thumbs-up for its biosimilar pegfilgrastim, Fulphila, which was launched in the U.S. in July at a 33 percent discount to the originator’s WAC (wholesale acquisition cost). 

In the past few years, I’ve often crossed paths at conferences with Chrys Kokino, the head of biologics and insulins for Mylan North America, but we were never officially introduced. As fate would have it, shortly after the launch of Fulphila, I had the opportunity to speak to Kokino. After all the development challenges for pegfilgrastim biosimilars and the commercialization challenges facing the industry, I was interested to hear about the work that went into getting Fulphila successfully to market.  

Throughout his career, Kokino has worked on both the innovator and biosimilar sides of a business. Because of this, he understands the importance of innovation, as well as biosimilar competition and sustainable development protocols. While we’ve heard about the systemic challenges standing in the way of biosimilars gaining payers’ favor, Kokino shared that Fulphila has not experienced similar market blockage so far.

“The launch has been very successful,” he shared. “We are facing demand from the marketplace for Fulphila, not only because of the work we did to lay the appropriate foundation for uptake and stakeholder trust, but also because providers were looking for treatment options which could provide a different value proposition.” During our conversation, Kokino and I walked through the steps Mylan took to establish this foundation, as well as how the company’s overseas biosimilar experiences influenced its global — including the U.S. — biosimilar launch strategy.  

Conversations Began In Advance, Sought Best Practices Advice

As head of biologics, Kokino oversees the commercial planning and readiness for Mylan’s biosimilars across therapeutic areas.  Having received marketing authorization for biosimilar products in over 35 countries thus far, Kokino speaks frequently with colleagues in India, Rest of World Markets, and Europe in order to monitor the performance of Mylan’s products, as well as uncover the trends impacting each market. In addition to analyzing the strategies abroad to inform the U.S. strategy, Kokino’s efforts to launch Fulphila in the U.S. also involved conversation surrounding the well-known generics company’s efforts to enter the biologics market.

When I first started writing about the biosimilar industry, I was fascinated by the diverse business models investing in biosimilars. As we all know, this industry comprises pure-plays, biotechs, Big Pharma, and Big Generic companies. It’s as diverse as it can get. And though commercializing biosimilars is more often associated with the commercialization of a brand product than a generic, even the most successful originator companies are not often finding biosimilars to be an easy or innate business transition. Indeed, as Kokino acknowledged, many of the experts on his team at Mylan, including himself, had come to the biosimilar table with experience in Big Pharma.

“We knew how to launch originator biologics,” he said. “There’s a well-established process in place to do that in Big Pharma. But what we did not know was, how will the launch of biosimilars be different? How would we position these products and to what audience? What type of patient support services would be required? What materials would be required? What about pricing?”

Building the appropriate foundation for Fulphila started when the company began interacting with multiple stakeholders engaged with biosimilars, such as clinicans, patients, payers, wholesalers, and group-purchasing organizations (GPOs). As Kokino pointed out, because these stakeholders had previous experiences with another biosimilar in the U.S., Mylan asked three important questions to help formulate its go-to market strategy: What worked well for each stakeholder in the roll-out of the other biosimilar? What didn’t work well, and what should Mylan do differently?

The number-one — and surprisingly simple — request of U.S. stakeholders was for basic information and to engage in conversations early on in the commercial launch. (In fact, I’ve written about the importance of early discussions with payers, most recently in an article in which one payer argued they should be approached as soon as a decision is made to commercialize a drug.)

Building A Scientific Presence

For a company like Mylan, which has a reputation for being a large pure-play generics company, building these partnerships early on involved venturing outside of the traditional biosimilar-centric education. Given the company’s work in the small molecule space, it was critical stakeholders understood the company’s entrance into biologics. Conversations evolved from Mylan’s growing biologics business and its biosimilar manufacturing process — including where the manufacturing takes place and its regulatory qualifications — to which products exist in the pipeline and the company’s overall strategy for each.

As Kokino pointed out, these early conversations would have proceeded quite differently for companies with a history in the biologics realm because they’d already be known in the large molecule space. “We had to start laying the appropriate clinical and scientific foundations,” he said.  

For example, the company’s experience with its trastuzumab biosimilar Ogivri played a critical role in building its biologics foundation. One key event was in 2016, when Mylan was the only manufacturer present at a late-breaking session of the American Society of Clinical Oncology (ASCO). It was there the company presented results from its then-ongoing HERITAGE study, in which the company confirmed the comparable efficacy, safety, and immunogenicity of Ogivri to Herceptin.

“You wouldn’t believe the flooding of messages we received following that presentation,” Kokino offered. “So many people reached out to say they didn’t even know Mylan was in this space and to express appreciation for the presentation of the data.” The HERITAGE study Phase 3 data went on to be published in the Journal of the American Medical Association (JAMA) and contributed to the company’s 2017 FDA approval.    

In addition to building a solid scientific foundation in the medical community, Kokino also emphasized the importance of looking at Mylan’s global biosimilar experiences in other countries. He referred specifically to the company’s experience with the launch of biosimilar trastuzumab in India (launched in 2014) where lessons were learned in regards to such things as messaging around biosimilars, product positioning, and patient support services.   

In an upcoming article, I will continue sharing my discussion with Kokino, particularly highlighting his thoughts on the state of the biosimilar market today, as well as how he sees Fulphila’s strategy evolving over time. Stay tuned!