Biosimilar Business Roundup: November 2019

During November, biosimilar developers announced a spate of new business agreements and acquisitions. November also saw biosimilars approved and launched, and innovator products’ sales slipping.

Among the biggest business news of the month was Teva and Celltrion’s launch of biosimilar rituximab, Truxima. The product is the first biosimilar rituximab to reach US patients and is offered at a list price that is 10% lower than the list price of the brand-name Rituxan. While the drug was only approved in oncology indications due to the patent landscape, the drug makers also announced that they have reached a settlement with Genentech that will now allow for the biosimilar to ask the FDA to grant indications in rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

But Truxima was not the month’s only launch. Sandoz launched its Ziextenzo, the third biosimilar pegfilgrastim, in the US market. That launch saw a relatively deep discount of 37% off the list price of the brand-name Neulasta. In an interview with The Center for Biosimilars^®, Sandoz’s Sheila Frame, MBA, vice president of marketing, market access, and patient services, said that being third to launch a biosimilar of a given reference put the company in a “very open and flexible and agile environment,” one in which the company will rely on the expertise of its commercial and medical teams to compete with other pegfilgrastim producers.

The US market could also see the launch of another biosimilar trastuzumab in the coming days. The FDA has issued an establishment inspection report for Biocon’s facility where its produces its biosimilars. Biocon indicated that, following the regulatory move, it will be able to launch its biosimilar trastuzumab, Ogivri, “soon” and said it will lead to “tremendous cost savings to the US healthcare system.”

Celltrion is also looking to future launches, having announced that it plans to launch 1 new product every year through 2023. The drug maker hopes those launches will include the company’s subcutaneous formulation of CT-P13, which this month received authorization from the European Commission. Sang Joon Lee, PhD, senior executive vice president of Celltrion, this month told The Center for Biosimilars^® that the company sees potential for the “biobetter” infliximab to compete with products like etanercept and adalimumab.

Looking to the next wave of its biosimilar products, Samsung Bioepis said this month that it has entered into a new commercialization agreement with partner Biogen for 2 ophthalmology biosimilars that are currently in development. The agreement relates to SB11, a proposed ranibizumab biosimilar referencing Lucentis, and SB15, a proposed aflibercept biosimilar referencing Eylea, in the United States, Canada, Europe, Japan, and Australia. SB11 is currently in a phase 3 clinical trial, while SB15 is in preclinical development. The agreement also gives Biogen the option to extend by 5 years its existing 10-year commercialization agreement for 3 anti—tumor necrosis factor biosimilars in Europe. Samsung Bioepis also announced this month that the FDA will review its bevacizumab biosimilar, SB8.

Meanwhile, Coherus BioSciences is also making strides in the ophthalmology space. The drug maker announced that it has acquired exclusive rights to Bioeq IP’s ranibizumab biosimilar. Bioeq plans to file a Biologics License Application for the biosimilar this quarter, and Coherus plans to launch the biosimilar in 2021.

Finally, Iceland-based Alvotech announced that it has entered into an exclusive partnership with Germany-based Stada to commercialize 7 biosimilars—including autoimmune, oncology, ophthalmology, and inflammatory disease therapies—in Europe.

Biosimilar competition took a bite out of AbbVie’s Humira revenues on the international stage; in its third quarter results, AbbVie said that its sales of the brand-name adalimumab had decreased by 33.5% on a reported basis after having faced competition from biosimilars outside of the US market. Those numbers reflect the strong performance of biosimilars in Europe, where health systems have made concerted efforts to adopt biosimilar adalimumab after the first products launched in October 2018.

Drug prices also continued to be a hot topic this month. During a meeting in London, United Kingdom, Justin McCarthy, JD, senior vice president of the patient and health impact group at Pfizer, said that he believes generics and biosimilars can be an important tool in making headroom for extremely high-cost treatments like gene therapies. These transformational treatments have been testing the limits of current strategies to pay for drugs, his fellow panelists said, but this month, other data show that existing drugs are continuing to see price hikes that may not be sustainable.

The AARP Public Policy Institute’s latest Rx Price Watch report showed that the prices of 267 brand-name drugs that are commonly used by older Americans rose by an average of 5.8%—more than twice the general rate of inflation, which was 2.4%. Other drug pricing research unveiled this month showed that, between 2012 and 2014, postmarket drug price hikes alone accounted for most of the recent spending growth on biologics, and manufacturers’ rebates had little impact. Additionally, price increases drove most of the spending growth for some of the oldest Part B drugs, including rituximab and infliximab.

And while high drug prices are a challenge worldwide, a report from the UK digital healthcare startup Medbelle shows that the United States pays more than other countries for many often-used drugs, deviating more than 300% from the median price for both brands and generics.

Meanwhile, a research letter in JAMA Internal Medicine questioned whether sales of one particularly high-cost biologic, brand-name eculizumab, may be coming from off-label use for nonapproved indications. According to the authors of that letter, Soliris garnered sales of $43.5 billion last year, and that large amount of revenue raises questions about whether the drug is being used in indications in which it has not been demonstrated to be effective.

Alexion, maker of Soliris, could also be in for a bumpy road ahead as it seeks to transition patients successfully treated with eculizumab to its longer-acting successor, ravulizumab (Ultomiris), ahead of biosimilar competition for eculizumab.

While approximately 51% of patients with paroxysmal nocturnal hemoglobinuria who were taking eculizumab have now been switched to ravulizumab, and phase 3 trials are underway for ravulizumab in other eculizumab indications, Roche’s Japan-based subsidiary, Chugai Pharmaceutical, filed a patent infringement suit against Alexion in the District Court of Delaware.

The complaint alleges that ravulizumab infringes on Chugai’s technology that extends the half-life of an antibody in blood plasma, improving the length of time for which the antibody can bind to and neutralize an antigen. Chugai has asked for injunctive relief to prevent ravulizumab from being manufactured, used, or sold.