Organon & Co.

China's drug supply chain, a Bayer biotech incubator and a Henlius biosimilar's FDA approval made our news this week. A new report finds China supplies many key pharmaceutical ingredients to the U.S. market. Bayer opened a new biotech incubator in Beijing. A first-of-its-kind biosimilar originally developed by Shanghai Henlius Biotech scored FDA approval. And more.1. U.S. ‘chained to China’ on pharma supply (report)Even as the industry’s top innovative drugmakers work to bolster their U.S. production footprints, many of those projects focus on the later stages of manufacturing, leaving a gap around domestically sourced drug building blocks. China, meanwhile, remains a key supplier of active pharmaceutical ingredients to the U.S., and especially those for generic medicines. The finding comes from an annual report (PDF) to Congress from the U.S.-China Economic and Security Review Commission. The report provides several recommendations to bolster the U.S. pharmaceutical supply chain, including expanded FDA authorities. 2. Bayer opens Beijing incubator and names initial occupants, tightening ties to China After breaking ground in 2023, Bayer has opened its biotech incubator in Beijing. Upon its opening, the Bayer E-Town Open Innovation Center will host Puhe BioPharma and Youngen Technology. The facility will assist local companies with innovative medicines in their efforts to bring the drugs to global markets.3. Organon and Henlius' Poherdy, first biosimilar to Roche's Perjeta, scores FDA nodOrganon and Henlius Biotech’s Poherdy has become the first biosimilar referencing Roche’s Perjeta to be approved by the FDA. The FDA granted the copycat an interchangeable tag for all existing indications of the original HER2 antibody. The nod came less than three months after the FDA cleared the partners’ biosimilars to Amgen’s bone med duo Prolia and Xgeva.4. Lilly inks $2.6B collab with Korea’s ABL Bio (release) Korea’s ABL Bio has linked arms with another Big Pharma company for its blood-brain barrier tech. This time, Eli Lilly will pay $40 million upfront and up to $2.6 billion to work with ABL across modalities and therapeutic areas. In addition, Lilly is making an equity investment worth 22 billion Korean won ($15 million), which ABL plans to use to advance its Grabody platform and bispecific antibody-drug conjugates.5. Celltrion still thinking bigger than biosimilars with option for $350M antibody deal Celltrion continues its business expansion beyond biosimilars. In a potential $350 million-plus deal, the Korean company obtained the option to use compatriot biotech TriOar’s tumor microenvironment-selective antibody platform for up to six targets. The move came a few days after Celltrion announced a deal for two preclinical autoimmune assets from Kaigene.6. Celltrion to widen US manufacturing reach with $478M investment at former Lilly plant In the U.S., Celltrion will spend up to 700 billion Korean won ($478 million) to upgrade the active pharmaceutical ingredient facility the Korean company recently bought from Eli Lilly for about $330 million. The investment in the Branchburg, New Jersey, plant is meant to address U.S. pharmaceutical tariffs, Celltrion said. Other News of Note: 7. CytoMed buys T cell tech with eye on treating cancer patients in China and India (release)8. Otsuka's HAE med Dawnzera, Lilly's oral SERD Inluriyo among drugs scoring EU endorsements9. JSR hands over Crown to Carlyle-backed lab service company in $204M deal 10. CSL charts US plasma manufacturing expansion with $1.5B investment  

Organon and Shanghai Henlius Biotech have obtained FDA approval for their Perjeta biosimilar, Poherdy. Image credit: Okrasiuk via Shutterstock.com. Shanghai Henlius Biotech and Organon have obtained US approval for their Perjeta biosimilar, Poherdy (pertuzumab-dpzb). This makes it the first interchangeable Perjeta biosimilar to gain approval from the US Food and Drug Administration (FDA). Like its branded counterpart, Poherdy will be available to patients with human epidermal growth factor receptor 2 (HER2)-positive, metastatic breast cancer. It will also be indicated for use in combination with trastuzumab and chemotherapy in both the adjuvant and neoadjuvant settings. This follows a comprehensive review from the FDA, which found that Poherdy is “highly similar to Perjeta”, with no clinically meaningful differences in efficacy and safety observed between the two products. The agency made this call based on the results of a pharmacokinetic (PK) study in healthy adults, as well as a Phase III trial in the neoadjuvant HER2-positive, HR-negative breast cancer setting. Poherdy’s approval comes after the FDA debuted plans to simplify the interchangeable biosimilar development process , which is set to help patients and prescribers identify low-cost brand alternatives more easily. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Organon’s commercial hurdle Following Poherdy’s approval, Organon will be responsible for the drug’s commercialisation across the US. This follows Henlius’ choice to out license the drug’s ex-China rights to Organon in 2022, which saw the latter hand over $103m for Poherdy and a Prolia/Xgeva (denosumab) biosimilar in 2022. These licensing deals are not the only moves the company has made to expand its biosimilar portfolio, as Organon also acquired the rights to Biogen’s Actemra (tocilizumab) biosimilar, Tofidence , in April 2025. Despite its newfound approval, Poherdy’s market entry may not be smooth sailing, as Perjeta maker Genentech is looking to hold back the tides on biosimilar competition for a little longer. In a bid to achieve this, the Roche subsidiary filed a lawsuit in August 2025 in the district of New Jersey, alleging that Shanghai Henlius Biotech and Organon are infringing on 24 US patents covering Perjeta’s market exclusivity. A verdict is yet to be reached. However, Genentech’s attempt to curb the sales losses of Perjeta comes as the drug’s sales are already experiencing a steady decline since its $4.3bn peak in 2021, according to GlobalData analysis. The same analysis predicts that sales in 2024 dropped to $4.1bn. Looking forward to 2031, analysts at GlobalData expect this trend to continue, as the drug is expected to bring in less than a quarter of its 2021 income, producing just $797m in sales. GlobalData is the parent company of Pharmaceutical Technology . The profit drop experienced by Genentech may be further exacerbated by the potential market introduction of new biosimilars, including EirGenix’s Perjeta mimic. Sandoz recently acquired the global commercial rights to the biosimilar outside of certain countries in Asia. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

The FDA approved Organon and Henlius Biotech's Poherdy as the first interchangeable biosimilar to Roche's Perjeta. As Roche works to switch certain patients with breast cancer over to a fixed-dose combination of two medicines, its 13-year-old drug Perjeta is inching toward the end of its exclusive run in the U.S.The FDA said Thursday that it has approved Poherdy as an interchangeable biosimilar to Perjeta. The agency’s endorsement covers the Roche drug’s existing HER2-positive breast cancer indications. Perjeta’s label currently includes its use in combination with trastuzumab and chemo for first-line HER2-positive metastatic breast cancer and as a neoadjuvant or adjuvant treatment for early-stage disease.Poherdy was originally developed by Henlius Biotech, which out-licensed ex-China rights of the drug—along with a copycat to Amgen’s Prolia-Xgeva duo—to Organon in 2022.The FDA said the approval, which allows pharmacists to substitute Poherdy for Perjeta without another prescription, was based on a “comprehensive review” of evidence showing the copy product is highly similar to Perjeta. The evidence includes comparisons across various quality attributes demonstrating similarity in the structural and functional features of the two products as well as results in humans confirming similar body exposure to the products following a single infusion.A parallel-controlled phase 3 showed Poherdy, also known as HLX11, matched up to Perjeta on efficacy and safety as a neoadjuvant therapy in HER2-positive early breast cancer, earning the biosimilar its “interchangeable” tag, according to the agency. It’s not clear whether Organon can immediately launch Poherdy. In its second-quarter earnings report (PDF) in July, Roche said it expects to face the first U.S. Perjeta biosimilars in 2026 as primary patents of the drug had expired in the second quarter earlier this year. The Roche drug won its original FDA approval in 2012.Roche and its U.S. subsidiary Genentech brought a patent infringement lawsuit against Henlius and Organon in August, asserting arguments around a laundry list of patents on Perjeta. Organon did not immediately respond to Fierce Pharma’s inquiry.Even before Perjeta’s eventual loss of exclusivity, sales of the drug have been in decline thanks to Roche’s efforts to switch patients to its Perjeta-Herceptin fixed-dose combination called Phesgo.In the first nine months of 2025, Perjeta sales were down 13% year over year to 2.3 billion Swiss francs ($2.9 billion), whereas Phesgo sales jumped 54% to 1.8 billion Swiss francs.More Perjeta biosimilars could be on their way. Sandoz just announced a deal licensing global commercial rights to EirGenix’s proposed pertuzumab product, excluding certain countries in Asia. Meanwhile, the biosimilar market may be poised for a renaissance. In recent draft guidance, the FDA said it’s taking steps to reduce clinical testing burdens for biosimilars and to categorize all approved biosimilars as “interchangeable” without requirements for switching studies. The new measures, according to FDA Commissioner Martin Makary, M.D., would cut the average development cost for biosimilars in half.