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Recent BioPharma & US Tariff Updates
- Jana Chisholm
- 4 days ago
- 7 min read
This week we've had Eyes On BioPharma updates and US Regulatory moves on EU Tariffs. Check out Lilly 's data and expectations for Verzenio, GSK's deal with Hengrui, Novo Nordisk & Replicate Bioscience's agreement on sRNA, and the latest on US-EU Pharma tariffs.
Verzenio, a product of Eli Lilly, has demonstrated the capacity to extend the survival of patients with high-risk early breast cancer that is HR-positive, HER2-negative, and node-positive. In the phase 3 monarchE study, Verzenio, when administered in conjunction with endocrine therapy following surgery, demonstrated a statistically significant and clinically meaningful improvement in overall survival when compared to endocrine therapy alone.
Verzenio’s unique profile in high-risk HR+, HeR2-early breast cancer is further supported by the fact that it can produce a statistically meaningful OS advantage after just two years of treatment. Kisqali from Novartis is taken for up to three years in the same adjuvant.
When Kisqali received a wider FDA approval in September 2024 for HR-positive, HER2-negative high-risk early breast cancer, the competition between the two CDK4/6 inhibitors reached a new stage. Crucially, some node-negative individuals are also covered by Kisqali’s designation. In the context of adjuvant treatment, such seemingly insignificant difference effectively gives Kisqali twice as many eligible patients as its competitor.
Both drugs had produced phase 3 data demonstrating their ability to reduce the risk of mortality or illness recurrence prior to Lilly’s announcement. Now, if the FDA approves, Lilly would soon be able to advertise Verzenio's overall survival improvement.
According to Lilly, the business will review the data with regulatory agencies and will present comprehensive results at a future medical hearing. It’s no minor accomplishment for Verzenio to achieve a statistically meaningful showing on overall survival. In the past, Verzenio’s phase 3 monarchE study in first-line advanced breast cancer came very close to missing the overall survival mark. Novartis won that readout because Kisqali is still the only CDK4/6 agent that has shown a benefit in life extension in that particular treatment context. The launch of Kisqali in early breast cancer, on top of all of this, keeps putting pressure on Verzenio’s growth prospects.
Pfizer’s first-to-market share leadership in the metastatic scenario was surpassed by the Novartis medication, which as of June was claiming a 61% new-to-brand U.S. patient share in the adjuvant setting.
Based on data, Kisqali’s growth momentum is unparalleled in the industry. The Novartis drug’s sales increased 64% year over year to $1.18 billion in the second quarter. In that same time frame, Lilly’s Verzenio revenue was $1.49 billion, a 12% increase over the previous period.
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Novo Nordisk is relying on innovative RNA technology to support its early-stage pipeline as the obesity pioneer loses ground in the competition for next-generation medications. Novo and Replicate Bioscience have signed a multi-year research agreement that could be valued up to $550 million. This agreement gives the company access to Replicate’s technology to target cardiometabolic disease.
As per the agreement, Novo will provide funding for Replicate’s research in exchange for the sole worldwide right to create and market the lead programs that might follow. Although specific disease targets were not revealed, the scientists intend to develop novel therapies for cardiometabolic conditions, including obesity and Type 2 diabetes.
Replicate will receive a $550 million agreement value payment in an upfront tranche as well as in milestones. Royalties from product sales resulting from the cooperation will also be given to the biotech.
Since Replicate creates self-replicating RNA (srRNA) molecules, which are made to replicate themselves and multiply once they reach the body, they can be administered at lower dosages than normal mRNA molecules. Once within a cell, the RNA serves as a guide for the natural machinery of the cell to produce a drug.
A COVID-19 vaccine employing a similar technology—Arcturus Therapeutics and CSL’s Kostaive—has been approved in Europe and Japan, and the biotech’s srRNA rabies vaccine just passed a phase 1 test. Replicate’s only clinical asset is the rabies vaccine; other preclinical candidates include molecules that target autoimmune diseases, lung cancer, and breast cancer, as well as a vaccine for the Epstein-Barr virus.
Prior to the rise of Eli Lilly as the main opponent and competition from compounders, Novo was the unquestioned heavyweight of the GLP-1 world. Due to recent market difficulties, the business’s long-time CEO Lars Fruergaard Jørgensen was fired this year. Novo veteran Maziar Mike Doustdar took over shortly after the company decreased its 2025 revenue projection because of the semaglutide market’s poor development.A GLP-1/GIP co-agonist and a CB1 receptor blocker were two obesity assets that Novo removed from its pipeline earlier this month.https://pharmatell.stu
Since Doustdar took over, Novo has approved Wegovy for the treatment of adult metabolic dysfunction-associated steatohepatitis and bid farewell to its senior VP of marketing and patient solutions for U.S. operations. A hiring freeze for non-business critical positions is currently being implemented.
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The White House has provided additional details on its plans to tax pharmaceuticals and other goods coming from the European Union, just under a month after the announcement of a comprehensive trade agreement between the US and the EU. Starting September 1, the U.S. will impose a 'Most Favored Nation' (MFN) tariff rate on generic drugs produced from the EU, including their ingredients and chemical precursors. According to the European Commission, that concealed MFN percentage will be practically zero or very nearly zero.Separately, the United States has reiterated its commitment to levy a base tariff rate of 15% on the majority of other European imports, including branded pharmaceuticals, as part of the initial conditions of the agreement outlined in July.
The deal’s provisions probably offer some respite to the EU’s pharmaceutical sector, which now seems to be exempt from the higher sectoral tariffs that the Trump administration intends to apply to other regions in the wake of a Section 232 investigation into the national security implications of drug imports from the United States.The original statements around the EU deal, which implied that some generic medications would be excluded from the 15% duty, are also clarified in the White House update. Industry observers were also uncertain whether Section 232 tariffs would alter the European baseline tariff rate prior to last week’s announcement.
According to analysts, the revelation of what seems to be a 15% cap on branded medications would likely allow organisations to proceed with greater assurance in their planning and strategy, even as they await the ultimate decision regarding complete section 232 tariffs pertaining to other countries.
Others, such as the trade association the European Federation of Pharmaceutical Industries and Associations (EFPIA), are not convinced of the trade deal’s advantages for the industry. According to the federation, the 15% tariff rate on branded medications violates a 30-year agreement between governments to safeguard patients by doing away with tariffs on cutting-edge medications and their constituent parts.Regarding the off-brand aspect of the agreement, India provides the United States with a significant amount of its pharmaceutical ingredients (35%) for generic medications. Europe accounts for 18% of the global market for generic active pharmaceutical ingredients (API), making it the second largest market. Approximately 12% of the components used in the generic medicine supply are produced in the United States.
Analysts, industry observers, and pharmaceutical executives have praised the capacity of big, creative pharmaceutical companies to withstand the worst of the tariff threats imposed by the Trump administration throughout the year. However, generic drug producers are in a far more vulnerable situation and are not as resilient to possible levies. In 2023, the FDA estimated that 91% of prescriptions in the United States were for generic medications.
Celltrion, Aurobindo, and Hikma, major players in the copycat medicine industry, recently committed to investments ranging from $250 million to $1 billion to strengthen their U.S. presence as the prospect of pharmaceutical tariffs has increased.Earlier this month, President Trump made a suggestion that, based on the findings of the Section 232 investigation, sectoral tariffs on medicines might begin modestly and then rise to 150% or 250% over the course of a year or two.However, it is far from clear when those responsibilities will be performed or how they will ultimately be enforced.
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GSK just received permission for Nucala in the treatment of chronic obstructive pulmonary disease (COPD), and now the pharmaceutical company has inked a significant $12 billion deal to bolster its product line for the respiratory ailment.
Hengrui Pharma is receiving $500 million in advance from GSK in a transaction that might involve up to 12 medications. Only one of these medications, a PDE3/4 inhibitor known as HRS-9821, was mentioned by the firms in their July 28 announcement. According to Hengrui, early clinical and preclinical studies have already shown that HRS-9821 has strong PDE3 and PDE4 inhibition, which results in improved bronchodilation and anti-inflammatory benefits.
In May, GSK received approval for Nucala, an IL-5 antibody, as an adjuvant maintenance treatment for people with eosinophilic phenotype and poorly managed COPD. By adding patients who experience persistent dyspnoea or who, according to their disease profile, are unlikely to receive inhaled corticosteroids or biologics, HRS-9821 advances GSK’s goal of treating patients with COPD over the broadest spectrum.
The partnership will include up to 11 other programs in addition to HRS-9821. Hengrui will always take the lead in development until phase 1 trials are finished. Afterwards, GSK will have the sole right to develop the assets and eventually market them outside of the greater China area.Beyond the fact that these initiatives have been chosen and are a complement to GSK’s substantial respiratory, immunology and inflammation (RI&I), and oncology pipeline, the firms did not disclose any more information about them.
Although each of these programs has a different financial structure, taken as a whole, the development, regulatory, and commercial milestone payments that Hengrui could receive could amount to an enormous $12 billion. However, it should be noted that these kinds of agreements rarely reach their full amount. Tiered royalties on sales outside of China would also be paid to Jiangsu, the China-based business.
The GSK agreement caps off an excellent year for Hengrui, which in May generated HK$9.89 billion ($1.29 billion) through an initial public offering (IPO) in Hong Kong. With remarkable weight loss data from its injectable GLP-1/GIP receptor dual agonist, the biopharma is getting ready to present to Chinese regulators after receiving a $200 million upfront payment from Merck & Co. for the rights to a phase 2-stage heart disease medication.
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