At J.P. Morgan Healthcare Conference, Mylan, Momenta, and AbbVie Discuss the Role of Biosimilars

During the 37th annual J.P. Morgan Healthcare Conference held January 7-10 in San Francisco, California, drug makers Mylan and Momenta explained the role that biosimilars will play in their growth, while AbbVie outlined its strategy for managing direct biosimilar competition.

Biosimilars Are Part of Mylan’s “Healthy Mix”

In a “fireside chat” discussion, Mylan Chief Executive Officer Heather Bresch, said that the dynamics of the healthcare market are becoming increasingly complicated, and that Mylan’s diversification—which includes biosimilars among its top 25 products—helps to create “a healthy mix” in its portfolio.

Yet, she said, the specialty marketplace, including biosimilars, has unique challenges. “Everybody talks about brand or generics, but I think we need to do a better job of calling out the specialty marketplace” and its challenges and opportunities, said Bresch, adding that this area has high investment coupled with slower uptake. “We have to be quick studies” to learn how to best navigate this field.

“I can assure you, we’ve applied learnings from our [generic glatiramer acetate] launch, from our [Fulphila]. We’ve continued to learn a lot.”

Mylan President Rajiv Malik said of the Fulphila launch, “We have been executing exactly the way we have modeled it,” saying that the biosimilar pegfilgrastim has now captured an approximate 18% to 20% market share.

Of biosimilar competitor Coherus and its recent launch of a pegfilgrastim biosimilar, he added that there is “opportunity for everybody.”

Momenta Plans to Fund Novel Agents With Biosimilar Sales

Craig A. Wheeler, chief executive officer of Momenta, opened his talk by saying that he wanted to “close the book on last year,” referring to the company’s October 2018 overhaul of its business.

Wheeler said that Momenta’s “declining opportunities and fortunes” in the biosimilars space—linked in part to a production partner’s Form 483 for a manufacturing plant—were part of the formula that led to a new focus on novel drugs targeting rare diseases and late-stage biosimilars. The shakeup also resulted in Momenta’s dropping 5 biosimilar programs in collaboration with Mylan and a 50% workforce reduction.

Momenta kept 2 biosimilar programs, and Wheeler explained that they were chosen because “The costs are behind us.” The first of the retained candidates, a fully developed proposed biosimilar adalimumab referencing Humira, was subject to a recent settlement with AbbVie that will allow for a 2023 US launch. Wheeler said that the company is now seeking commercialization collaboration for the product “so we can actually get some value out of it.”

The second retained program is a proposed aflibercept biosimilar referencing Eylea (developed in collaboration with Mylan). Enrollment is ongoing for a pivotal phase 3 trial of the molecule, and Wheeler said that Momenta expects the drug to launch in 2023. “It made all the sense in the world” to continue with this this product, he said, as its development is ahead of other such biosimilar candidates in this space.

Once in the market, these biosimilars are expected help to fund expensive phase 3 trials for Momenta’s novel agents. Among those products is an anti—neonatal Fc receptor agent. Momenta sees this drug as having the potential to treat 45 autoimmune diseases, to treat 8 or more indications in maternal–fetal disorders, and to limit the immunogenicity of gene therapies. “We’d like to be the Humira in the category,” he said, indicating that the company sees best-in-class potential for the drug.

The company is now in a phase 2 study of the product in myasthenia gravis, an area also targeted by Alexion (and biosimilar developers eyeing Alexion’s eculizumab).

AbbVie Plans to Manage Biosimilar Competition Through Its Novel Agents

For the first time, AbbVie is facing competition for its blockbuster adalimumab, Humira. In his presentation, Michael Severino, vice chairman and president of AbbVie, reassured investors that the company is prepared to manage “the planned impact of direct biosimilar competition” for Humira’s $6 billion business through sales of its novel agents.

“We have long been diligently preparing for this event,” he said, through the development of a robust portfolio of new products.

According to Severino, non-Humira sales will grow to more than $35 billion by 2025, driven by AbbVie’s hematologic oncology drugs, as well by upadacitinib and risankizumab in the immunology space. These 2 products, which have potential in 12 or more indications and could contribute $10 billion in sales by 2025, will “ultimately replace Humira” as AbbVie’s lead assets in immunology, said Severino.

In total, AbbVie has 25 new molecules under investigation for immunology, he said, and among those drugs is a novel anti—tumor necrosis factor/steroid antibody–drug conjugate.