Presenters during the 37th annual J.P. Morgan Healthcare Conference, held January 7-10 in San Francisco, California provided an overview about what potential investors can expect to see from their companies’ pharmaceutical pipelines over the next fiscal year.
Presenters during the 37th annual J.P. Morgan Healthcare Conference, held January 7-10 in San Francisco, California provided an overview about what potential investors can expect to see from their companies’ pharmaceutical pipelines over the next fiscal year.
Johnson and Johnson Expects to Maintain Market Hold on Remicade
Joseph Wolk, executive vice president and CFO of Johnson and Johnson (J&J), opened up the company’s “fireside chat” by explaining that he expects J&J to have a strong 2019, coming off of a strong 2018. “We’re really optimistic about some new products to be filed in 2019 [across a spectrum of disease states], and we definitely foresee that the positive momentum will continue.” In terms of diversification of the business, Wolk was firm: “We’ll go where the science takes us and where we have the capabilities and expertise to win.”
In terms of competition, J&J is the developer of reference infliximab, sold as Remicade. Wolk said that, from an operational perspective, the company will be seeing significant patent expiration this year. Additionally, “We’re going to continue to see Remicade biosimilar competition, potentially for Procrit as well…but we still expect to grow in pharmaceuticals. We expect to be above market growth levels in 2020.” Importantly, Wolk noted that J&J’s pharmaceuticals business has seen 7 years of above-average market growth.
Jennifer Taubert, executive vice president, worldwide chair of pharmaceuticals, fielded a question regarding J&Js 4% to 5% pricing decrease seen in 2018. “A lot of that is because we chose to compete with Remicade and put additional discounts and rebates into the market,” she said. Taubert went on to explain that the company is “successfully competing for access for patients in the market,” and that “We think we’re well poised for the future where we do think that prices will be moderated.”
Biogen Sees Successful Biosimilar Launch, Looks to Future
Biogen’s CEO, Michel Vounatsos, explained the impact that biosimilars have had not just on the company, but for patients across Europe.
“Biosimilars [are] very important in our corporate value proposition where we engage with payers because they help create headroom for innovation, or neuroinnovation, as I call it,” referencing Biogen’s focus on neuroscience products.
Biosimilars currently account for 4% of the company’s total revenue from its partnership with Samsung BioLogics in Samsung Bioepis, said Vounatsos, and nearly 100,000 patients are currently taking Biogen’s biosimilars. Its etanercept biosimilar, Benepali, has seen “uptake [that has] led to estimated healthcare savings of up to €800 million [approximately $916] annually across Europe.”
Most recently, Biogen launched its adalimumab biosimilar, Imraldi, in Europe in October 2018. Vounatsos told investors they can expect more data to come about the adalimumab biosimilar’s launch on an upcoming earnings call.
“Biosimilars are another tremendous success, a half-billion-dollar franchise we launched in Europe, and we have the potential to double this revenue in the coming years,” said Vounatsos.
While Vounatsos said that he remains confident in the biosimilars portion of the business, he’s not sure that the “mechanics are in place [in the United States] for the system to benefit from these savings.”
In terms of the future of Biogen’s biosimilar arm, Vounatsos plans to leverage the joint venture agreement with Samsung. Recently, Biogen increased its equity stake in the company to 49.9% and plans to utilize Samsung’s expertise in protein engineering and biologics manufacturing to further advance the development of trastuzumab and bevacizumab biosimilars.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy
November 27th 2024The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.
Ocrelizumab Biosimilar Shows Equivalent Efficacy as Multiple Sclerosis Treatment
November 26th 2024The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.