Eye on Pharma: BI Cyltezo Partnership; Europe Ustekinumab Launch; Mexico Biosimilar Approval

Boehringer Ingelheim (BI) partnered with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launched in Europe; and Mexican officials approved a bevacizumab biosimilar.

BI, GoodRx Partnership

BI and GoodRx announced a patient affordability initiative to provide BI’s citrate-free unbranded biosimilar adalimumab-adbm, which references Humira (adalimumab), at a low cash price exclusively on GoodRx.¹ This FDA-approved biosimilar treats autoimmune conditions like rheumatoid arthritis, juvenile idiopathic arthritis, ulcerative colitis, and Crohn disease. The partnership aims to enhance access and affordability for this high-cost medication. The biosimilar is an unbranded version of Cyltezo (adalimumab-adbm).

Starting July 18, the program offers high- and low-concentration formulations of adalimumab-adbm as prefilled syringes or autoinjectors at $550 per 2-pack, a 92% discount from Humira's list price. This initiative allows anyone with a valid prescription to purchase the drug at over 70,000 retail pharmacies nationwide, regardless of insurance status, potentially speeding up therapy access for patients.

"Patients with certain chronic inflammatory diseases who do not have insurance or are underinsured may not be able to afford essential biologic medicines, including biosimilars, to treat their disease," said Chris Marsh, senior vice president of value and access at Boehringer Ingelheim. "Partnering with GoodRx to offer our biosimilar adalimumab-adbm at a low price to these patients helps us deliver on our commitment to lowering financial barriers and improving access to critical treatments."

Cyltezo launched on the US market in July 2023 as 1 of 10 adalimumab biosimilars to launch that year. Cyltezo was the first adalimumab biosimilar to be approved with an interchangeability designation and is available in both a citrate-free high-concentration formulation and a low-concentration formulation.

Ustekinumab Biosimilar Launches in Europe

STADA Arzneimittel and Alvotech have launched Uzpruvo, the first approved ustekinumab biosimilar in Europe, across major European markets following the expiry of the reference molecule (Stelara) patent.² Uzpruvo is indicated for Crohn disease, psoriatic arthritis, and plaque psoriasis. It features a thinner needle compared with the reference product and is latex-free to minimize allergic reactions. The companies noted that the biosimilar, developed and manufactured entirely in Europe, has a 36-month shelf life.

“With comparable safety, efficacy and immunogenicity, Uzpruvo gives clinicians an opportunity for a seamless and simple switch for their patients, who can benefit from a thinner needle and latex-free syringe,” commented STADA’s global specialty head, Bryan Kim. “Physicians and patients can have full confidence that STADA has more than 15 years of experience in enhancing patient access through high-quality biosimilars in Europe, having launched our first biosimilar in 2008.”

Uzpruvo is STADA’s seventh biosimilar in Europe, complementing its offerings in bone health, nephrology, oncology, and ophthalmology. Alvotech, a global leader in biosimilars, has a portfolio of 11 biosimilars and has launched the Stelara biosimilar in Canada, Japan, and now Europe.

Mexico Gains a Bevacizumab Biosimilar

Zydus Lifesciences received approval from Mexico’s COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) to market Bhava, a bevacizumab biosimilar for various cancers.³ Bhava will be available in 100 mg/4 mL and 400 mg/16 mL strengths. Zydus initially launched this biosimilar in India in 2015 as Bryxta, with about 50,000 patients receiving the biosimilar since launch.

As of July 23, 2024, Zydus Lifesciences' shares were trading at $13.74, down 0.39% from the previous close but have gained 87% in the past year.

The FDA recently issued 2 observations about Zydus's transdermal manufacturing site, which the company is addressing. Formerly known as Cadila Healthcare Limited, Zydus is a prominent Indian pharmaceutical company.

References

1. Boehringer Ingelheim and GoodRx announce exclusive patient affordability initiative for Adalimumab-adbm injection, Boehringer's biosimilar to Humira®. Boehringer Ingelheim. Press release. July 18, 2024. Accessed July 22, 2024. https://www.prnewswire.com/news-releases/boehringer-ingelheim-and-goodrx-announce-exclusive-patient-affordability-initiative-for-adalimumab-adbm-injection-boehringers-biosimilar-to-humira-302199865.html

2. STADA and Alvotech launch Uzpruvo, the first approved ustekinumab biosimilar to Stelara, across Europe. Avotech. Press release. July 22, 2024. Accessed July 23, 2024. https://investors.alvotech.com/news-releases/news-release-details/stada-and-alvotech-launch-uzpruvo-first-approved-ustekinumab

3. Zydus secures COFEPRIS approval for Bhava biosimilar in Mexico. IIFL Securities. July 23, 2024. Accessed July 23, 2024. https://www.indiainfoline.com/news/business/zydus-secures-cofepris-approval-for-bhava-biosimilar-in-mexico