MET-097

iStock, z_wei The settlements delay the entry of generic copies of Pfizer’s Vyndamax by almost three years, stabilizing sales of a drug that generated $3.8 billion in the U.S. last year. Pfizer has reached settlements with three generic drugmakers, delaying the entry of off-patent rivals to its blockbuster heart disease drug Vyndamax until mid-2031. Prior to the settlements, Pfizer anticipated a significant decline in U.S. Vyndamax revenues beginning in 2029 upon patent expiry. The drugmaker reported $3.8 billion in U.S. sales of Vyndamax and related products in 2025. Having settled with Dexcel Pharma, Hikma Pharmaceuticals and Cipla, Pfizer predicted that U.S. Vyndamax sales will now remain relatively stable from 2028 through mid-2031. S&P Visible Alpha’s pre-settlement consensus was that Vyndamax U.S. sales would fall from $3.6 billion in 2028 to $1.8 billion in 2029, Leerink Partners analysts said in a Tuesday note to investors. Analysts expected the slide to continue, with the consensus being that U.S. sales of the cardiomyopathy transthyretin-mediated amyloidosis (ATTR-CM) drug would sink to $1 billion in 2030 and $600 million in 2031. Leerink analysts said delaying the entry of generic copies will support higher cash flows for Pfizer. Yet the length of the delay may disappoint some observers, with the analysts noting that some buyside investors hoped Pfizer could defer generic competition until closer to the expiry of a polymorph patent in 2035. Cardiovascular disease Pfizer Mounts Defense of Cardiac Blockbuster as Alnylam, BridgeBio Enter Market Alnylam and BridgeBio are competing for people who are switching from Pfizer’s blockbuster ATTR amyloidosis drug tafamidis while all three companies are fighting for new patients. April 22, 2025 · 5 min read · Nick Paul Taylor Read more With generic competitors arriving in 2031, the anticipated erosion of Vyndamax sales now falls outside of the period in which Pfizer expects its loss of exclusivity headwinds to peak. Loss of exclusivity on key products could create a $1.5 billion headwind for Pfizer this year, rising to $4.5 billion in 2027, CEO Albert Bourla said at the J.P. Morgan Healthcare Conference in January. Maintaining Vyndamax sales beyond 2029 could help Pfizer “stabilize the revenue base through this window while supporting confidence in the sustainability of the current dividend,” BMO Capital Markets analysts said in a note to investors. Pfizer is racing to bring molecules, including obesity drug candidate MET097 and PD-1/VEGF bispecific antibody PF-08634404, to market to drive growth in the 2030s. The settlement has implications for Pfizer’s rivals in the ATTR-CM market, which now know when their products will face competition from potentially cheaper generic copies of Vyndamax. Delaying the entry of Vyndamax generics until 2031 “represents an upside scenario” for BridgeBio Pharma’s ATTR-CM drug Attruby, Truist Securities analysts said in a note to investors. Yet BridgeBio’s share price closed down 6.5% at $69.66 on Tuesday. Truist analysts’ positive take on the outcome reflected their assumption that Vyndamax would lose exclusivity in 2028. Some investors were hoping Pfizer could delay generic competition until 2033 or as long as 2035, William Blair analysts said in a note to investors. William Blair analysts said Attruby sales could keep growing amid generic competition.

Long-awaited glucagon-like peptide-1 agonist (GLP-1) tablets don’t appear to be stealing significant market share from GLP-1 injectables. Rather, industry experts told MD+DI that they expect injectable versions of GLP-1s for weight loss and diabetes will continue to thrive. This is on the heels of FDA’s approvals of Novo Nordisk’s Wegovy (semaglutide) in December 2025 and Eli Lilly’s Foundayo (orforglipron) in April 2026. Injectable manufacturers and pharma remain bullish As pills gain a foothold in the colossal GLP-1 market, West Pharmaceutical Services announced in late March that it is revving up injectable therapy manufacturing capacity with a new 165,000 square foot facility. West manufactures primary packaging for injectable drugs. The company operates 26 manufacturing facilities worldwide and delivers more than 41 billion components and devices each year. Big pharma continues its push to develop competitive GLP-1 injectable options. Pfizer, which halted studies for two obesity pills since 2023 due to safety concerns, could strike weight loss gold with its investigational PF-08653944. If approved, Pfizer’s drug candidate will be a once-monthly GLP-1 injection, compared to weekly injections needed with today’s top GLP-1 sellers by Lilly and Novo Nordisk . People often flock to oral, vs. injectable, options GLP-1s might be changing typical consumer behavior, according to Jennifer Lake, PharmD and PhD, assistant professor at the University of Toronto. “Traditionally … what we would see is that when there becomes an oral option, people would switch to it. People don’t always like giving themselves injections,” Lake said. However, with GLP1s, many patients who have started on injectables are quite happy to continue on them. One of the reasons is that today’s self-injectors, especially single-use pre-filled syringes, have fine needles that cause less pain compared to vaccination or blood draw needles, according to Lake. Mina Tadrous, PharmD, PhD, professor of pharmacy at the University of Toronto, points to several other factors that weigh in injectables’ favor. While pills are taken daily, injection administration might be once weekly. Another factor: newer drug formulations and biologics enter the market as injectables, and manufacturers tend to release pill versions later. “If I had to bet, I would say that you're not going to see less injectors, you're going to probably see more,” Tadrous said. Big picture for injectables GLP-1s are but one class in the broader pharma injectable market. Shane Campbell, senior vice president, Chief Proprietary Segment Officer, at West, told MD+DI that injectables are outgrowing orals across pharma. The trend reflects a fundamental shift in the types of molecules being developed. Campbell said the injectable drug pipeline has expanded about 2.5-fold over the past decade, with approximately 64% of drug development focused on high‑value, low‑volume therapies, which structurally favor biologics — specialty, injectables, and complex delivery systems. “From a global pharma spending perspective (2025–2035), injectables are projected to grow at about 9% CAGR, vs. about 5% for orals. This growth is being driven primarily by large molecules, expected to grow at roughly 10% CAGR, and by delivery innovation, particularly autoinjectors, which are growing at about 11% CAGR and increasingly define the route‑of‑administration value proposition,” according to Campbell. GLP‑1s follow this injectable‑led growth pattern but with some nuances. Unlike many biologics, GLP‑1s are competing head‑to‑head across routes of administration. Injectables have the momentum due to superior efficacy, durability of weight loss, and dosing convenience (weekly or longer), Campbell noted. “That said, GLP‑1s are relatively distinct in sustaining meaningful investment in oral formulations, which is atypical for large molecules. This reflects the mass‑market scale of obesity and diabetes, where oral options could materially expand access, persistence, and earlier therapy initiation or continuation of treatment for patients moving from injectable to orals,” Campbell said. “Consensus estimates see the market for oral formulations stabilizing at about 30%.” Limited head-to-head data comparing newer oral therapy to injections have shown similar safety and efficacy. Clinical trial data showed patients taking oral Wegovy lost an average of 13.6% of body weight at 71 weeks, while comparable injectable GLP-1 trials have shown average weight loss to be between 15% to 20%. Pills seem to result in similar side effect profiles compared to injectables, according to Yale Medicine . Injectable business as usual? Increased insurance reimbursement, Medicare expansion, pricing reductions, the arrival of generics, and new GLP-1 indications are among the factors that will drive continued growth for injectables and pills. More broadly, biologics and biosimilars are leading the charge in growth and development, according to Campbell. “Growth in advanced and complex molecules (biologics, [monoclonal antibodies] mAbs, novel modalities) is reshaping injectable development,” Campbell said. Still, oral options will likely impact the market positively in terms of accessibility (an option for needle-phobic patients) and affordability. Not only are newer orals like orforglipron less expensive to produce because they don’t include devices, like prefilled syringes or injectors, but orforglipron isn't a protein-based molecule. Orforglipron is a chemical-based molecule that is cheaper to produce, according to Lake. And tablets are more sustainable than injectables. For now, weekly, even monthly injectables, have a larger environmental footprint than 90 to 100 tablets in a vial, Lake noted. Pharma is working to make injectables more sustainable. One example, FDA recently approved Lilly’s KwikPen, which delivers a month of Zepbound GLP-1 in one device . Global injectable market Campbell pointed to geographical nuances within the injectable medicine ecosystem. Many view the U.S. as a leader in innovation and complex biologics, particularly for advanced combination products and self-injection systems. This is driven by a strong biotech sector and early adoption of home-based care, he said. “Western Europe is known for precision engineering, high-quality sterile manufacturing, and deep regulatory expertise, especially in containment and delivery systems,” Campbell said. “Meanwhile, countries in Asia, such as Singapore, South Korea, and China, are rapidly expanding biologics and biosimilar manufacturing capacity, offering scalability, speed, and growing technical sophistication, often supported by strong government investment. India plays a major role in cost-efficient generics and high-volume sterile production.” Continued growth for injectables likely Pharma pipelines are increasingly dominated by large, complex molecules, where injectable delivery delivers more consistent and reliable outcomes. This will continue to drive injectable market growth, Campbell said. “Safety differences tend to be molecule and indication-specific rather than route-driven, and regulators evaluate benefit–risk case by case,” Campbell said. “In parallel, advances such as long-acting formulations and autoinjectors have enabled greater patient adherence and continue to improve patient experience and overall quality of life. GLP-1s illustrate this well: injectables lead today because they deliver better clinical outcomes, while continued oral innovation reflects market expansion and access potential for a larger patient population.” Groups continue to innovate the ways in which peptide- and protein-based biologics (including GLP-1 medications) are administered. While current methods have transformed modern therapeutics, “…they remain constrained by poor oral bioavailability, stability challenges, cold-chain dependence, and limited patient acceptability associated with injectable administration,” according to a review in AAPS PharmSciTech . Recent technological advances for GLP-1s include microneedle-assisted delivery systems, the researchers wrote.