Sandoz AG

MEDIA RELEASE First FDA-approved abbreviated new drug application (ANDA) to reference medicineSingle-dose 100 mg vial for intravenous use, approved for metastatic breast cancerLaunch expected to be near-term growth driver in US market Princeton, NJ, October 11, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that it has launched a generic paclitaxel formulation in the US, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA). Sandoz paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the treatment of patients with metastatic breast cancer. The launch of the lyophilized powder for injection containing 100 mg of paclitaxel in a single-dose vial for intravenous use follows approval by the FDA on October 8, 2024. Keren Haruvi, President, Sandoz North America, said: “An estimated 168,000 women in the US are living with metastatic breast cancer. [1] While rare, men can also develop metastatic breast cancer. [2] This milestone is another proof point of our commitment to provide access to life-changing medicines for all who need them.” Sandoz paclitaxel protein-bound particles for injectable suspension (albumin-bound) was developed in partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd., and is the first FDA-approved ANDA to reference product Abraxane®* for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension, albumin-bound). *Abraxane® is a registered trademark of Abraxis BioScience LLC, a Bristol-Myers Squibb Company. About paclitaxel protein-bound particles for injectable suspension (albumin-bound) INDICATIONSPaclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. SELECT IMPORTANT SAFETY INFORMATION WARNING: SEVERE MYELOSUPPRESSIONSee full prescribing information for complete boxed warning. Do not administer paclitaxel protein-bound particles for injectable suspension (albumin-bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm3.Monitor for neutropenia, which may be severe and result in infection or sepsis.Perform frequent complete blood cell counts on all patients receiving paclitaxel protein-bound particles for injectable suspension (albumin-bound). CONTRAINDICATIONSNeutrophil counts of < 1,500 cells/mm3; and severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound). WARNINGS AND PRECAUTIONSSensory neuropathy occurs frequently and may require dose reduction or treatment interruption. Sepsis occurred in patients with or without neutropenia who received paclitaxel protein-bound particles for injectable suspension (albumin-bound) in combination with gemcitabine; interrupt paclitaxel protein-bound particles for injectable suspension (albumin-bound) and gemcitabine until sepsis resolves, and if neutropenia, until neutrophils are at least 1,500 cells/mm3, then resume treatment at reduced dose levels. Pneumonitis occurred with the use of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in combination with gemcitabine; permanently discontinue treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound) and gemcitabine. Severe hypersensitivity reactions with fatal outcome have been reported. Do not rechallenge with this drug. Exposure and toxicity of paclitaxel can be increased in patients with hepatic impairment, consider dose reduction and closely monitor patients with hepatic impairment. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) contains albumin derived from human blood, which has a theoretical risk of viral transmission. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ADVERSE REACTIONSThe most common adverse reactions (≥ 20%) in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea. DRUG INTERACTIONSUse caution when concomitantly administering paclitaxel protein-bound particles for injectable suspension (albumin-bound) with inhibitors or inducers of either CYP2C8 or CYP3A4. USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. This is not the complete list of all the safety information for Paclitaxel protein-bound particles for injectable suspension (albumin-bound). Please click to see the full Prescribing Information for Paclitaxel protein-bound particles for injectable suspension (albumin-bound). DISCLAIMERThis Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. References[1] National Institutes of Health. NIH MedlinePlus Magazine. Quick Facts on Metastatic Breast Cancer. Available at Quick facts on metastatic breast cancer | NIH MedlinePlus Magazine. [Last accessed: September 2024][2] American Cancer Society. Treatment of Breast Cancer in Men, by Stage. Available at Treatment of Breast Cancer in Men, by Stage | American Cancer Society. [Last accessed: September 2024] ABOUT SANDOZSandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz recorded sales of USD 9.6 billion. CONTACTS US Media Relations contactsInvestor Relations contactsMediaInfo@sandoz.comInvestor.Relations@sandoz.comLeslie Pott+1 609 422 4150Laurent de Weck+41 79 795 7364Vicki Crafton+1 201 213 6338Tamara Hackl+41 79 790 5217 Attachment Paclitaxel US Media Release

Comparable clinical efficacy and safety in Treatment Period 2 (TP2, Week 24-48) is maintained after switch from reference tocilizumab to TOFIDENCE (BAT1806/BIIB800) Phase 3 clinical data in totality demonstrates biosimilarity between TOFIDENCE (BAT1806/BIIB800) and reference tocilizumab before and after switching.1,2 GUANGZHOU, China, Sept. 11, 2024 /PRNewswire/ -- Bio-Thera Solutions, Ltd. today announced, in collaboration with Biogen, the publication in the journal Arthritis Research & Therapy of results from Treatment Period 2 (TP2; study weeks 24-48) of a Phase 3 clinical study evaluating BAT1806/BIIB800, an approved biosimilar to Actemra®/RoActemra®3 (tocilizumab). BAT1806/BIIB800 is currently commercialized under the brand name TOFIDENCE™4. In the Phase 3, multicenter, multiregional, double-blind, active-controlled, clinical equivalence study, participants with active rheumatoid arthritis (RA) despite treatment with methotrexate were randomized (1:1:2) to intravenous (iv) administration of 8 mg/kg reference tocilizumab (TCZ) every 4 weeks to week 48 (TCZ group), or TCZ to week 24 followed by BAT1806/BIIB800 to week 48 (TCZ to BAT1806/BIIB800 group), or BAT1806/BIIB800 to week 48 (BAT1806/BIIB800 group)1,2. Efficacy in TP2 of the study was evaluated using American College of Rheumatology (ACR) response criteria (ACR20/50/70) and change from baseline in Disease Activity Score on 28 joints (DAS28)2. Pharmacokinetics, safety, and immunogenicity were also evaluated. TP2 analysis also assessed the possible impact of a single treatment switch from TCZ to BAT1806/BIIB800 after week 24, reflecting clinical practice where multiple treatment switches occur. Results from TP2 of the Phase 3 study demonstrated maintenance of comparable clinical efficacy, safety, immunogenicity and PK following switch to BAT1806/BIIB800 from TCZ, in patients with Rheumatoid Arthritis and an inadequate response to methotrexate. "We are pleased to publish the switching data of TOFIDENCE (BAT1806/BIIB800) from reference tocilizumab that strongly supports its biosimilarity to tocilizumab for a long-term period in treating patients with active rheumatoid arthritis and an inadequate response to MTX," said Dr Xiaolei Yang, Executive Medical Director for Rheumatology and Immunology at Bio-Thera. "We hope the study results help allay any concerns over safety and efficacy of TOFIDENCE (BAT1806/BIIB800) for use in patients who were previously treated with reference product." Bio-Thera Solutions, Ltd. and Biogen entered into a commercialization and license agreement to develop, manufacture and commercialize TOFIDENCE (BAT1806/BIIB800) on April 8th, 2021. Biogen has exclusive regulatory, manufacturing and commercial rights to TOFIDENCE (BAT1806/BIIB800) in all countries excluding China (including Hong Kong, Macau and Taiwan). BAT1806/BIIB800 TP2 Analysis Of 621 randomized participants, 577 (92.9%) completed Treatment Period 1 (TP1, Week 0-24) and entered TP2 (TCZ: N = 145 [93.5%]; TCZ to BAT1806/BIIB800: N = 142 [92.2%]; BAT1806/BIIB800: N = 290 [92.9%])1,2. Proportions of ACR20 responders were similar between treatment groups throughout TP2 (87.8%, 90.3%, and 90.4%, respectively, at week 48), as were proportions of ACR50 and ACR70 responders, and reduction in DAS28. Drug trough levels and antidrug antibody incidences were comparable between the treatment groups. Adverse events were balanced across the treatment groups and no fatal events were reported. In TP2, efficacy, safety, immunogenicity, and pharmacokinetic profiles were comparable between the TCZ, TCZ to BAT1806/BIIB800, and BAT1806/BIIB800 groups. These longer-term findings reinforce the results reported for TP1 and further support biosimilarity. About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including four approved products: QLETLI®5 and BETAGRIN®(Bevifibatide Citrate Injection) in China, and TOFIDENCE/ BAT1806 and Avzivi®6 / Pobevcy®7 in the US, EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera). Bio-Thera Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to BAT1806 or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. 1. Leng X, Leszczynski P, Jeka S, et al. Comparing tocilizumab biosimilar BAT1806/ BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial. Lancet Rheumatol. 2024;6(1):e40-50 2. Leng X, Leszczynski P, Jeka S, et al. A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a proposed tocilizumab biosimilar, with a tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 and week 48). Manuscript in review 3. Actemra® / RoActemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp, a member of the Roche Group 4. TOFIDENCE™ is a trademark of Biogen 5. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. 6. Avzivi® is a registered trademark of Sandoz AG 7. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. MEDIA CONTACT – BIO-THERA SOLUTIONS, LTD. Bert E. Thomas IV +1.410.627.1734 [email protected] SOURCE Bio-Thera Solutions, Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

GUANGZHOU, China, July 25, 2024 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177: SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that dosing has recently begun in an integrated Phase I / Phase III clinical study for BAT3306, a proposed biosimilar of Keytruda® (pembrolizumab). The clinical study is a randomized, double-blind, parallel group, active control study to compare the pharmacokinetics, efficacy and safety of BAT3306 to Keytruda® in non-squamous non-small cell lung cancer (nsNSCLC) patients. The study is expected to enroll approximately 676 patients. "Keytruda is the most important innovative cancer therapy currently in use," said Shengfeng Li, CEO at Bio-Thera. "Bio-Thera is committed to expanding access to this important cancer therapy with the development of BAT3306." Bio-Thera Solutions is developing a large pipeline of biosimilars that include BAT1806, a tocilizumab has been approved by FDA, EMA and NMPA, BAT1706, a bevacizumab has been approved by FDA and NMPA. BAT2206, a ustekinumab has been filed with FDA, EMA and NMPA. Bio-Thera Solutions is also pursuing biosimilar versions of golimumab, secukinumab, and mepolizumab. About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including three approved products: QLETLI® (BAT1406) in China, TOFIDENCE™/ BAT1806 in the US, EU and China and Avzivi® / Pobevcy® (BAT1706) in the US and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera). Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to BAT3306 or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. 1. Keytruda® is a registered trademark of Merck Sharp & Dohme 2. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. 3. TOFIDENCE™ is a trademark of Biogen 4. Avzivi® is a registered trademark of Sandoz AG 5. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. Contact Bio-Thera Solutions, Ltd.: Bert E. Thomas IV +1.410.627.1734 [email protected] SOURCE Bio-Thera Solutions, Ltd