The Center for Biosimilars

 that it plans to spin off Sandoz, its generics and biosimilars division, into a new publicly traded, standalone company.

In a statement, Novartis said the plan seeks “to maximize shareholder value by creating the number one European generics company and a global leader in biosimilars, allowing Novartis shareholders to participate fully in the potential future upside,” for both Sandoz and Novartis Innovative Medicines.

Sandoz will be incorporated in Switzerland and listed in Swiss Exchange, SIX, with an American Depositary Receipt (ADR) program in the United States, the statement said. Novartis officials said they expect the plan to be tax neutral; while subject to market conditions, tax rulings, and shareholder approvals, it is expected to be complete in the second half of 2023.

As a standalone company, Sandoz will be able to focus its existing biosimilars pipeline of more than molecules. In the statement, Novartis said it aims to become “a focused innovative medicines company with a stronger financial profile and improved return on capital.”

“Our strategic review examined all options for Sandoz and concluded that a 100% spinoff is in the best interest of shareholders,” said Joerg Reinhardt, Chair of the Board of Directors of Novartis, in the statement. “A spinoff would allow our shareholders to benefit from the potential future successes of a more focused Novartis and a standalone Sandoz, and would offer differentiated and clear investment theses for the individual businesses.”

Vas Narasimhan MD, CEO of Novartis, said, “For Novartis, the separation of Sandoz would further support our strategy of building a focused innovative medicines company, with depth in 5 core therapeutic areas, and strength in technology platforms. 

In addition, both companies would be able to focus on maximizing value creation for their shareholders by prioritizing capital and resource allocation, employing separate capital structure policies, and increasing management focus on their respective business needs.”

The 5 core therapeutic areas are hematology, solid tumors, immunology, neuroscience, and cardiosvascular medicine.

According to Novartis, Sandoz generated $9.6 billion in 2021 and served more than 100 markets globally, with a strong presence in Europe as well as in the United States. Sandoz plans to continue investment in the key biosimilars, antibiotics and generic medicines.

Articles

The move will create Europe's largest generics company.

Novartis to Make Sandoz a Stand-alone Company

FDA has accepted the biologics license application (BLA) for Fresenius Kabi’s biosimilar candidate for tocilizumab, the 

The candidate, MSB11456, would reference Actemra, an immunosuppressive drug used to treat autoimmune conditions that include moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

According to a statement from the company, the BLA submission includes analytical similarity and comprehensive clinical data needed to demonstrate  similar pharmacokinetic, efficacy, safety, tolerability, and immunogenicity to the reference product, with and without switch from tocilizumab to MSB11456. The application features presentations for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations. In its statement, the company said it anticipates FDA approval in 2023.

“The FDA’s acceptance of the BLA for our proposed tocilizumab biosimilar candidate is an important step forward in bringing a wider range of affordable and accessible autoimmune treatment options to patients and health care providers while reducing the cost burden to health care systems,” Michael Schönhofen, PhD, Fresenius Kabi chief operating officer and management board member, said in the statement. “We are rapidly expanding and investing in our biosimilars portfolio for autoimmune and cancer-related conditions, including R&D and manufacturing, to be a reliable biosimilars partner in the United States and worldwide.”

Fresenius Kabi recently acquired a majority stake at mAbxience, which strengthened its biosimilars portfolio and offered access to new manufacturing capabilities. The proposed tocilizumab biosimilar candidate would complement other products in a portfolio that includes the company’s adalimumab biosimilar, Idacio, which is commercialized in more than 34 countries and is under FDA review. 

In a statement, Fresenius Kabi officials said the company is rapidly expanding its portfolio in autoimmune and oncology conditions. 

BLA Accepted for Fresenius Kabi Tocilizumab Biosimilar

The Coherus biosimilar ranibizumab-eqrn, which references the injectable Lucentis, received FDA approval 

, bringing more competition to the ophthalmology market after years in which expensive injectable therapies for retinal conditions brought in billions in sales.

The vascular endothelial growth factor (VEGF) inhibitor, to be sold as Cimerli, was desginated as an interchangeable biosimilar across all 5 indications, with 12 months’ exclusivity on interchangeability. Another ranibizumab biosimilar, 

, is approved, but Coherus’ product is the first deemed interchangeable, which involves additional FDA requirements that allow substitution without intervention of the prescribing clinician, subject to state pharmacy laws. Lucentis 

In a statement, Coherus’ Chief Commercial Officer Paul Reider said the status will ensure greater access and choice for patients with retinal disease. “Coherus is the only company in the $7 billion anti-VEGF ophthalmology market with a demonstrated track record of US commercial biosimilar success,” he said.

The company plans to launch Cimerli in October in both 0.3 mg and 0.5 dosages. Retinal indications for which Cimerli is interchangeable are: neovascular (wet) age-related macular degeneration, or AMD; macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

The product is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products.

 and the interchangeable desgination were based on several studies, including the 

. This head-to-head study showed Cimerli met its primary end point of change from baseline in best corrected visual acuity at week 8 compared with the reference ranibizumab.

Another ranibizumab biosimilar, Byooviz, is approved, but Coherus’ product is the first deemed interchangeable, which involves additional FDA requirements that allow substitution without intervention of the prescribing clinician.

FDA Approves Coherus’ Cimerli as Interchangeable Biosimilar to Ranibizumab

Generic drug manufacturer Teva Pharmaceuticals would pay $4.25 billion to settle more than 2500 lawsuits with states, local governments, and tribes over its role in the opioid epidemic under a settlement announced late Tuesday.

Teva, based in Israel, was one of the largest makers of prescription painkillers at the peak of the opioid crisis. 

 the epidemic has claimed more than 932,000 US lives since 1999, including 69,000 in 2020.

The deal follows a string of trials and settlements totaling $550 million in separate cases around the country. It was announced by several state attorneys general who brokered the tentative agreement. A total of 12 states have taken part in the negotiations, according to a statement from 

, who noted that talks between Teva and New York State continue.

“This agreement is another major step toward addressing the opioid crisis and healing our communities,” Bonta said. “Nothing can undo the harm opioids makers like Teva have inflicted on families across the country or the lives lost to the opioid epidemic. But this agreement will provide much-needed relief for its victims and importantly, critical funds for overdose prevention and opioid addiction disorder treatment.”

Teva makes Actiq and Fentora, which are branded fentanyl products for cancer pain, as well as generic opioids that include oxycodone. The states claimed Teva had promoted rapid-onset fentanyl drugs for use outside cancer treatment, downplayed addiction risks, and failed to comply with suspicious order monitoring requirements.

States have the option of accepting supplies of naloxone, which can reverse an opioid overdose. The deal calls for Teva to provide up to $1.2 billion worth of generic naloxone, according to Bona’s statement.

The California official said that final settlement “remains contingent on agreement on critical business practice changes and transparency requirements.” Both Allergan, a generics manufacturer acquired by Teva, and various state governments must sign off on a final deal.

The deal follows a string of trials and settlements totaling $550 million in separate cases around the country.

Deal Would Have Teva Pay $4.25 Billion to Settle US Opioid Lawsuits

Teva Pharmaceuticals on Monday launched lenalidomide capsules, the generic of Revlimid, in the United States. The capsules are available in 5 mg, 10 mg, 15 mg, and 25 mg strengths, according to a statement from the company.

Lenalidomide is used in regimens to treat multiple myeloma, mantle cell lymphoma, and certain myelodysplastic syndromes. Bristol Myers Squibb’s Revlimid, developed by Celgene, was a long-time money maker—the statement from Teva cited IQVIA data that put annual sales at $2.3 billion, although some reports put the 2021 figure well above that.

Revlimid’s pricing history—and the corporate strategy to keep competitors at bay—made it a poster child for 

 has become a bipartisan policy issue. In a 2018 report, National Public Radio profiled patient David Miller, who founded a patient advocacy organization after watching the price of Revlimid double from $8000 to $16,691 per month when he took it from 2010 to 2016.

Meanwhile, the Medicare co-pay rose from $115 to $690 per month, according to information HHS released at the time.

“The launch of our first generic version of Revlimid in the US provides patients with another important treatment option for these extremely challenging conditions, demonstrating Teva’s commitment to making complex generic drugs available to the patients who need them,” Christine Baeder, chief operating officer, US Generics, Teva USA, said in the statement. “This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization.”

Teva’s launch makes it the first competitor to Revlimid in the United States, but perhaps not the last. The news comes as other generics manufacturers 

 plans for their own versions of lenalidomide in Europe.

Teva’s launch makes it the first competitor to Revlimid in the United States, but perhaps not the last.

Teva Announces US Launch of Lenalidomide, Generic of Revlimid

Prestige BioPharma has announced that the manufacturing facility for Tuznue, a proposed trastuzumab biosimilar, has received European Union (EU) Good Manufacturing Practices (GMP) certification. A 

 from Prestige BioPharma described the EU-GMP certification as “one of the highest standards of pharmaceutical production in the world,” one that gives companies a path to bring therapies to market in Europe.

Tuznue, which references Roche’s Herceptin, can be used to treat HER2+ breast and metastatic gastric cancer and has been evaluated in a phase 3 trial. The therapy is currently under review for marketing authorization by the EU European Medicines Agency, Canada, and South Korea. 

According to the statement, Prestige Biopharma’s research pipeline includes biosimilars and first-in-class therapies, including biosimilars referencing Avastin and Humira.

“EU-GMP certification of our manufacturing arm in Korea demonstrated our global standard biomanufacturing facility and system that are applied to all of our products,” said

Lisa S. Park, CEO of Prestige BioPharma. “By achieving one of the key requirements for product registration, we are one step closer to global launch of Tuznue that can enhance affordability of trastuzumab to the patients in need.”

Tuznue, which references Roche’s Herceptin, is currently under review for marketing authorization by the EU European Medicines Agency, Canada, and South Korea. 



Prestige BioPharma’s Manufacturing Facility for Trastuzumab Biosimilar Receives EU-GMP Certification

The International Generic and Biosimilar Medicines Association (

 with 13 leaders from companies based in Europe, the United States, Canada, India, Israel, and Japan.

The IGBA, which dates to 1997 when it was founded as the International Generic Pharmaceutical Alliance, is incorporated in Geneva, Switzerland, and is an accredited member of the World Health Organization. According to the group’s website, the IGBA maintains dialogue with other national, regional, and international bodies to ensure patient access to high quality, safe, and effective medicines while reducing costs in pharmaceutical care.

Vivian Frittelli, IGBA chair, said forming the CEO Advisory Committee will be a “transformative” step for the group. “This is the first time that the generic and biosimilar medicines industry’s company leadership has united in a structured framework, enabling a collective voice in the global pharmaceutical space,” he added.

Members of the CEO Advisory Committee include:

, president and Co-CEO of Amneal Pharmaceuticals Inc.

, chair of Dr. Reddy’s Laboratories Ltd.

, CEO and chairman, Executive Board, STADA Arzneimittel AG

, managing director, Sun Pharmaceutical Industries Ltd.

, president and CEO, Teva Pharmaceuticals Industries Ltd.

, CEO, Towa Pharma International Holdings S.L.

"I am happy to join the CEO Advisory Committee set up by the IGBA,” said Shanghvi, of Sun Pharmaceuticals. “The generic and biosimilar industry leaders of 13 leading multinational companies coming together for the first time to discuss critical global healthcare policy issues is a great step."

Added Peix, of Towa Pharma, "This advisory committee represents a milestone for the 13 worldwide leading companies of generic, value added and biosimilar medicines. For the first time, we are officially together on facing the main actual challenges and we are all working by our common purpose: the patients."

The IGBA maintains dialogue with other national, regional, and international bodies to ensure patient access to high-quality, safe, and effective medicines while reducing costs in pharmaceutical care.

IGBA Launches Panel of 13 CEO-Level Advisers

Alvotech Holdings announced today it has entered into a global licensing agreement with BiosanaPharma for the co-development of a proposed biosimilar, AVT23, for the reference product Xolair (omalizumab). The announcement was made in a joint statement by the 2 companies.

Omalizumab is an antibody that targets free IgE and helps control of symptoms from several chronic conditions, including allergic asthma, long-term spontaneous urticaria (itchy rash) in patients with elevated IgE who do not respond to treatment with antihistamines, and nasal polyps in adults when corticosteroids do not offer enough relief.

Xolair, the only currently approved product containing omalizumab, was first approved in 2003. AVT23 is an investigational compound and has not received regulatory approval in any country.

The proposed biosimilar AVT23 would be produced using BiosanaPharma’s proprietary 3C process technology, which the companies said allows for “highly productive, low-cost manufacturing.”

“This transaction underscores Alvotech’s comprehensive approach to the biosimilars market,” Mark Levick, CEO of Alvotech, said. “Our pure-play biosimilars approach allows the Alvotech platform to be highly opportunistic in not only developing products in-house, but also through in-licensing and co-developing attractive products through partnerships with premier companies like BiosanaPharma.”

“We are delighted at this collaboration with Alvotech as their platform can enable global distribution of our lead product, if approved,” said Ard Tijsterman, CEO of BiosanaPharma. “Our 3C process technology is designed to make products more affordable and to improve patient access, a key goal for both BiosanaPharma and Alvotech.”

“The cooperation between our companies demonstrates the ability of our platform to rapidly scale our portfolio,” said Anil Okay, Chief Commercial Officer of Alvotech.“This product had been on our wish list for some time and expands the breadth and potential of our future offerings in primary care.”

Under the agreement, Alvotech will receive exclusive global rights for AVT23, a proposed biosimilar to Xolair. BiosanaPharma will receive an upfront payment and will be eligible for certain tiered royalties. BiosanaPharma and Alvotech will jointly continue development of AVT23, currently in late-stage development. BiosanaPharma has completed a pharmacokinetic (PK) study showing that AVT23’s bioavailability, safety, tolerability and immunogenicity were comparable to those of Xolair.

Global sales of Xolair are currently estimated at $3.3 billion.

Alvotech, based in Iceland, focuses on development and manufacture of biosimilar medicines. The company’s pipeline includes 8 candidates for treating autoimmune disorders, eye conditions, osteoporosis, and cancer. BiosanaPharma, with operations in Australia, the Netherlands, and Singapore, aims to increase affordability by using its proprietary 3C process.

Xolair, the only currently approved product containing omalizumab, was first approved in 2003. AVT23 is an investigational compound and has not received regulatory approval in any country. Current sales of Xolair are estimated at $3.3 billion.

Alvotech Enters Licensing Agreement With BiosanaPharma for Development of Biosimilar for Xolair

Anti—tumor necrosis factor biosimilars for the treatment of inflammatory disease present attractive cost savings for both payers and patients. A free, continuing education broadcast on September 29, 2020, at 8 p.m. will address the identification of patients most likely to benefit from biosimilars for inflammatory conditions, review current clinical evidence and real-world data on the use of these agents, and demonstrate how to develop evidence-based protocols for reducing expenditures and improving access to these treatments. This program is for managed care pharmacists and other interested clinicians and will be presented by Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars for Cardinal Health. For more information or to register for the "Treating Inflammatory Conditions With Biosimilars" symposium, please click 

A September 29, 2020, symposium with Sonia T. Oskouei, PharmD, BCMAS, DPLA, of Cardinal Health will explore how to incorporate biosimilars into the treatment of inflammatory conditions. 

Symposium: Treating Inflammatory Conditions With Biosimilars

The FDA has approved 28 biosimilar products, 16 of which have indications for patients with cancer. These include versions of the monoclonal antibodies trastuzumab, bevacizumab, and rituximab, as well as biosimilars for the supportive care agents pegfilgrastim, filgrastim, and epoetin-alfa.

Integrating biosimilars further into cancer care will require an educational outreach, according to Ali McBride, PharmD, MS, BCOP, clinical coordinator of Hematology and Oncology in the Department of Pharmacy at the University of Arizona Cancer Center and immediate past president of the Association of Community Cancer Centers (ACCC).

 with OncLive.com, he discusses the age of biosimilars, the ACCC’s initiative to broaden acceptance and use of these drugs, and the knowledge gaps that need to be filled to ensure biosimilars are properly understood.

Ali Mcbride, PharmD, MS, BCOP, is taking a lead role in promoting the use and understanding of biosimilars in oncology.