Does the direct-to-employer route for biosimilars make sense? Employers have strongly indicated that they would like to move away from the big 3 PBMs for cost transparency and the ability to capture as much of the savings as possible themselves. Going the direct-to-employer route, as Waltz Health and Fresenius Kabi are doing, would seem a natural option. Waltz Health, a digital health company, has announced that it has agreed to team with Fresenius Kabi to help supply its three biosimilars in a direct-to-employer arrangement through its existing Waltz Connect platform. First reported by Fierce Healthcare, the biosimilars that will be available direct-to-employer will be Fresenius Kabi's Idacio (adalimumab), Tyenne (tocilizumab), and Otufli (ustekinumab). Waltz Health already has direct-to-employer arrangements with Eli Lilly and Novo Nordisk for their GLP-1 products. By using Waltz Connect, corporate members can avoid traditional wholesaler and pharmacy benefit manager arrangements (and thus avoid rebate contracts). As the products are still delivered through specialty pharmacies, the typical provider and patient supports can still be provided. The direct-to-employer benefit for biosimilars. This channel would appear to assure that patients directly benefit from discounts received by the corporate employer. In Fierce Healthcare, Fresenius Kabi's President of Biopharma Sang-Jin Pak, MD, stated, "As we continue to expand our biosimilars portfolio, we remain focused on innovative partnerships that help employers and payers access high-quality treatment options." Employer benefit consultant F. Randy Vogenberg, PhD, told BR&R, "Making the costly drug purchase experience easier and engaging for the consumer as patient remains important. Leveraging biosimilar solutions could further the value to employers and their plan beneficiaries (patients) as other market forces change coverage affecting access to treatment options." Dr. Vogenberg, Principal, FRV Health Strategy Advisory, Greenville, SC, said, "Addressing economic coverage gaps can be a win-win short-term solution for multiple stakeholders." Assuming that the employers signing onto Waltz Health have access to the same pricing for biosimilars as PBMs and others do, this seems a natural option. In surveys, employers have strongly indicated that they would like to move away from the big 3 PBMs for cost transparency and the ability to capture as much of the savings as possible themselves. In other biosimilar news. Teva Pharmaceuticals received its second FDA approval for its denosumab biosimilar. After receiving its approval for Ponlimsi in March, referencing Prolia, to prevent osteoporosis, Degevma, referencing Xgeva, will be prescribed to prevent skeletal-related complications in patients with multiple myeloma or bone metastases. Teva plans to launch both products "in the coming months." It joins a crowded field of 9 manufacturers with both denosumab indications. Meitheal Pharmaceuticals announced September 28 that the FDA approved its high-concentration formulation of Yusimry, the company's adalimumab biosimilar. The company will now be able to compete for prescriptions for this most-used adalimumab biosimilar formulation. "With this approval, we now have FDA approval for both low- and high-concentration formulations of Yusimry, marking an important step in expanding treatment options for patients with certain chronic autoimmune diseases," said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. In July, the company had also received FDA approval for its insulin aspart biosimilar Garzulys, which is produced by Emerge Bioscience. Meitheal has marketing responsibility for this agent. This article was written by its Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry's original, comprehensive and updated database of biosimilar filings with the FDA.

Why Waltz Health, Fresenius Kabi are taking biosimilars Direct. Waltz Health and Fresenius Kabi will offer three biosimilars through a direct-to-payer model that bypasses traditional wholesaler and PBM rebate channels. Waltz Health and Fresenius Kabi are giving employers and payers a direct contracting channel for three biosimilars through the Waltz Connect platform, sidestepping rebate structures that typically govern specialty drug access.[1] The partnership was announced as payers face growing pressure to manage specialty drug costs. In an email statement to Pharmaceutical Commerce, Jeff Park, president of Waltz Health, said "Employers and payers are looking for new approaches because specialty drugs are a growing share of pharmacy spend, while the economics behind what they ultimately pay can be difficult to see and manage."[2] "A large rebate does not necessarily mean the lowest net cost, particularly as more biosimilars and lower-cost alternatives enter the market," he added. What is included in the Waltz Health-Fresenius Kabi agreement? The agreement covers adalimumab-aacf, a biosimilar to Humira (AbbVie); Otulfi (ustekinumab-aauz), a biosimilar to Stelara (Johnson & Johnson); and Tyenne (tocilizumab-aazg), a biosimilar to Actemra (Genentech). The three products span rheumatology, dermatology and gastroenterology, three major inflammatory disease categories where Waltz Health and Fresenius Kabi said the pricing model is designed to help commercial plans manage the cost of care.[1] Plan members will access the at a defined price per unit, with Waltz Health applying a flat, previously disclosed fee. Final member cost will vary by pharmacy fees and each plan sponsor's benefit design, according to Waltz Health.[1] How does the direct-to-payer model work? Under Waltz Health's Direct-to-Payer program, employers and other plan sponsors contract directly with Waltz Health to offer eligible medications to covered members at pre-negotiated,, without relying on the traditional rebate structures that route through PBMs. Eligibility and pricing are verified through the Waltz Connect platform before fulfillment.[1] Prescriptions will be filled through a dedicated specialty pharmacy operated by EVERSANA, Waltz Health's parent company, and delivered directly to patients' homes. The model bypasses traditional wholesaler distribution and rebate-driven PBM channels, reducing intermediary cost, while maintaining the clinical support typically associated with specialty pharmacy, according to the companies. The expansion builds on Waltz Health's earlier rollout of direct-to-payer access for anti-obesity GLP-1 medications, marking the platform's first extension into biosimilars. Why is direct-to-payer contracting gaining traction now? Direct-to-payer arrangements for high-cost drugs, first popularized through GLP-1 programs from manufacturers including Eli Lilly and Novo Nordisk, have expanded as plan sponsors look to "evaluate alternative pricing structures for medications that have historically been difficult to cover due to cost volatility and complex rebate dynamics," according to a January 2026 analysis from law firm Morgan Lewis. Traditional PBM arrangements "have long relied on rebate-driven economics, often with limited transparency into true net cost," the analysis noted, while direct models offer "simpler, more transparent pricing, clearer terms, and defined clinical rules."[3] "We believe will become an increasingly important part of the solution because they can establish clear, upfront economics and give plan sponsors more control over how they access the lowest-cost therapy," Park said in his statement to Pharmaceutical Commerce.[2] "But getting a good price is only the first step. The real opportunity is connecting that price to the benefit, identifying the right pharmacy, routing the prescription appropriately, and supporting the patient through fulfillment." What are the commercial and market access implications for manufacturers? For manufacturers, the deal illustrates a channel strategy built on a flat transparent price negotiated directly with plan sponsors, fulfilled through an aligned specialty pharmacy rather than traditional wholesaler and PBM distribution. Fresenius Kabi frames the move as part of a broader push to expand access to biological therapies through commercial partnerships outside conventional channels. "That is where we see the market heading: not simply direct contracting, but intelligent orchestration of specialty medications around the lowest net cost and the best path for the patient," Park said.2 "The models that can do that at scale should create more competition, greater transparency and a simpler experience for employers, payers and patients." As extends from GLP-1s into biosimilars, the Waltz Health-Fresenius Kabi agreement points to a broader test of whether manufacturers and platforms can build durable commercial channels circumventing PBM rebate structures. References. * Waltz Health and Fresenius Kabi. "Waltz Health and Fresenius Kabi Expand Direct Access to Biosimilars Through Waltz Connect Platform." Press release, September 29, 2026. * Park, Jeff. President, Waltz Health. Email statement to Pharmaceutical Commerce, September 29, 2026. * Fattahian, Saghi, and Lindsay M. Goodman. "Straight to the Source: What Direct Drug Models Mean for Employer Plan Sponsors in 2026." Morgan Lewis LawFlash, January 13, 2026.