Pipeline Report: Oncology Biosimilars to Advance in 2020

Although makers of biosimilars often fight an uphill battle to get established, there’s evidence that they are gaining ground, Ann McNamara, PharmD, explained in a drug pipeline report for the Specialty Therapies and Biosimilars Congress.

“The good news is biosimilars are definitely starting to make traction within our health system. Prescribers are starting new patients on biosimilars. They’re doing that sometimes irrespective of payer policies on biosimilars,” said McNamara, director of clinical development for Fairview Specialty Pharmacy of Minneapolis, Minnesota.

In 2019, the FDA approved 10 biosimilars, among them products for breast cancer, metastatic stomach cancer, metastatic colorectal cancer, non-squamous non—small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, B-cell non-Hodgkin lymphoma, and chronic lymphocytic leukemia.

In the oncology space, multiple launches of biosimilars for breast cancer medication trastuzumab and lymphoma/leukemia drug rituximab could happen in 2020, McNamara said.

For trastuzumab, those could include Teva Pharmaceutical’s Herzuma and Merck’s Ontruzant; Ontruzant is slated to become part of a new spinoff company Merck annouced last week. Pfizer’s Trazimera is scheduled to launch February 15. These would join already launched trastuzumab biosimilars Kanjinti (Amgen) and Ogivri (Mylan) in the struggle to carve market share from Genentech’s originator brand Herceptin.

For rituximab in 2020, the FDA is reviewing Amgen’s AMG 798, which would join Pfizer’s recently launched Ruxience and Teva’s Truxima in the marketplace with the Genentech originator Rituxan.

Another biosimilar under FDA review at this stage is bevacizumab biosimilar SB8 from Samsung Bioepis. If it gains approval, it could join Amgen’s Mvasi and Pfizer’s Zirabev in the competition for a piece of Avastin’s market share.

The originator pegfilgrastim product (Neulasta), for helping the body recover its white blood cell count following cancer treatment, face 3 available biosimilars: Mylan’s Fulphila, Coherus’ Udenyca, and Sandoz’s Ziextenzo. Another potential new entrant in 2020, McNamara said, is the Pfizer/Hospira biosimilar HSP 130, which remains under FDA review.

Acceptance of these pegfilgrastim biosimilars has been slowed, but not halted, by Amgen’s counter strategy, which was to switch patients to its OnPro device for enabling users to self-dose at home rather than going to a doctor’s office or hospital. The device was launched in 2015 and as of early 2019 had a 62% share of the market, leaving the door open to biosimilar competition.

“Biosimilars to Neulasta may be an option for a smaller subset of patients who cannot use the Neulasta OnPro, but Neulasta OnPro really hasn’t done a good job of maintaining the Neulasta market,” McNamara remarked.

At the end of 2019, Udenyca and Fulphila had 20.5% and 6.0% shares of the pegfilgrastim market, respectively, according to a report from Coherus BioSciences. Udenyca’s growth made it the most successful biosimilar launch in the United States to date. Sales for Neulasta in 2019 were down 28% at $3.22 billion.

Another originator brand white blood cell booster, filgrastim (Neupogen), has 2 biosimilars on the market currently: Sandoz’s Zarxio and Pfizer’s Nivestym.

Tanvex’s TX01 is under FDA review, but NcNamara didn’t peg it as a likely market contender for 2020. In September, Tanvex got a complete response letter from the FDA indicating the review cycle for TX01 was complete but certain items needed to be addressed before resubmission of the application for approval.

Upcoming patent expirations for oncology medications include a 2020 exclusivity end for panitumumab (Vectibix), a treatment for cancer of the colon or rectum.

McNamara cautioned that the expiration of a patent for a leading brand doesn’t guarantee the entry of one or more biosimilars. “Some may be moving targets due to patent litigation,” she said. The other possibility is that the brand drug may have been displaced by a newer formulation or novel compound with greater efficacy.