The Center for Biosimilars

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.

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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.

ACCC's McBride on the Need for Biosimilar Education

Having 5 trastuzumab biosimilars with indications for HER2-positive breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma illustrates the increasing role of these more cost-effective treatments.

Ruth O’Regan, MD, believes the evidence indicates these agents are similar in efficacy and safety to the originator drugs, and for this reason they should be employed more often by providers and patients.

In this way, the problem of financial toxicity can be diminished, said O’Regan, a professor of medicine in the Division of Hematology and Oncology at the University of Wisconsin School of Medicine and Public Health and associate director for Clinical Research at University of Wisconsin Carbone Cancer Center in Madison.

In a recent interview, O’Regan discussed access to biosimilars, the provider-patient conversation about using these drugs, and education issues that must be surmounted.

Currently, much of the power over drug choice belongs to payers, she said. “At the end of the day, we don’t make the decisions on which drugs to use.” She said she’s confident that payers will naturally be interested in biosimilars because they offer potential savings and, for this reason, biosimilars are going to become more and more available. She anticipates that at Carbone biosimilars are going to have a “very profound effect” on the costs of care.

For reasons of cost, it may be preferable to switch patients from more costly reference drugs to biosimilars. “They may be apprehensive to go on an alternative drug. However, we may have no option. We’re developing educational information for the patients so that they understand these drugs are essentially the same,” O’Regan said.

Knowing how to discuss biosimilars with patients is, therefore, important, she said. For starters, patients should be told that these drugs are the same, essentially, and that they cost less. Although biosimilars are intravenous formulations and look different from generic pills, for example, patients should know that there is no reason to believe that they wouldn’t be just as effective, she said.

“We need to reiterate that these drugs have been tested and they look exactly the same as the parent drug,” O’Regan said.

For patients just starting out with treatment, there’s likely to be less resistance to initiating with a biosimilar. “For patients with metastatic disease who are very dependent on [reference] drugs and have been doing well, it may be a little trickier.” In such an instance, bringing the pharmacist into the examination room to help explain that biosimilars are equivalent may be a useful strategy, she said.

The National Comprehensive Cancer Network (NCCN) has been a helpful advocate for biosimilars for several years now, O’Regan said. “This is very much on their radar. What the NCCN recommends will impact what is being done on a national level.”

Ruth O’Regan, of the University of Wisconsin Carbone Cancer Center, discusses improving the patient discussion on biosimilars, in an interview.
 

Carbone Professor: Biosimilars Have Important Role to Play

With 1 biosimlar launch and expanded indications for another biosimilar so far this year, Teva Pharmaceutical Industries has 

 higher biosimilar revenues for the first quarter of 2020 compared with the same time last year.

Biosimilar income helped to offset declines in revenue from generic products in the first quarter for Teva. For both categories, however, revenues were $952 million for the first quarter of 2020, which is down 1% compared with the first quarter of 2019.

The company attributed the decline to price erosion for its products and lower royalty income, offset by an increase in revenues from launches of new products, including the rituximab biosimilar Truxima. Revenues for Truxima were not disclosed.

Truxima was launched in November 2019 for the treatment of CD20-positive, B-cell non-Hodgkin lymphoma either as monotherapy or in combination with chemotherapy. Following the resolution of a patent dispute, the product became 

 this month for treatment of rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

Overall, Teva's revenue for the first quarter of this year was $4.4 billion, which is an increase of 5% versus the year-ago quarter.

“Our very strong results during the first quarter of 2020 were impacted by greater demand in our major markets for generic and [over-the-counter] products and respiratory products,” said Kare Schultz, Teva’s president and chief executive officer.

The company reported net income for the quarter of $69 million, up from a loss of $105 million in the year-ago quarter.

In March of this year, Teva launched its trastuzumab product, Herzuma, in the United States. At present, the company has multiple biosimilars in preclinical and phase 1 development.

Teva has undergone a large-scale restructuring over the past 2 years, during which it sought to cut spending, reduce its workforce, and close manufacturing sites. For the quarter just ended, Teva said it had reduced its debt load by $600 million, leaving $24.3 billion in accounts payable.

With 1 biosimilar launch and expanded indications for another biosimilar so far this year, Teva Pharmaceutical Industries reported higher biosimilar revenues in the first quarter of 2020.

Teva Moves Further out of Debt and Gains Biosimilar Revenue

Eye health business Bausch + Lomb said it has entered into an agreement to commercialize in the United States and Canada a ranibizumab biosimilar candidate (Xlucane) currently under development.

The deal is with STADA Arzneimittel AG, of Bad Vilbel, Germany, and its development partner Xbrane, of Solna, Sweden. Xbrane announced 

 that it hopes to complete clinical trial enrollment for the age-related macular degeneration agent despite the limitations imposed by coronavirus disease 2019 (COVID-19) issues. Bausch + Lomb is headquartered in Laval, Canada.

The biosimilar references Lucentis, Novartis’ blockbuster drug, which loses its patent exclusivity in the United States this year and in Europe in 2022.

The partners in the biosimilar deal aim to obtain all currently approved indications for Lucentis. In the United States, the agent is approved for wet age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema.

STADA and Xbrane will be jointly responsible for finalizing development of the biosimilar, and Xbrane will be the commercial supplier. Bausch + Lomb will handle the sales, marketing, and other commercialization efforts in both the United States and Canada, assuming regulatory approval is obtained.

“We believe that, once approved, this biosimilar ranibizumab candidate will be an excellent addition to our comprehensive eye health portfolio and further deliver on our commitment of continuing to expand and improve upon our ophthalmic portfolio for our customers and their patients,” said Yolande Barnard, vice president and general manage of US Pharmaceuticals for Bausch + Lomb, in a 

Company officials said they believe the biosimilar candidate has strong commercial potential in the North American marketplace. Indeed, Lucentis netted global sales of $2.1 billion in 2019.

COVID-19 has forced modifications in clinical trials to accommodate for patients’ inability to get to clinics. The danger of COVID-19 infections has also forced curtailment of some trial activities. However, Xbrane in April reported that it is on track toward approval of Xlucane ahead of the European expiration of Lucentis’ patent in 2022.

Bausch + Lomb has secured the rights to commercialize a ranibizumab biosimilar in the United States and Canada.

Bausch + Lomb Secures Commercialization Deal for Ranibizumab

Biosimilar competition took a big bite out of revenues for Amgen, although the company’s own biosimilar portfolio notched impressive growth, according to Amgen’s first quarter 2020 earnings. The company said the coronavirus disease 2019 (COVID-19) pandemic has caused a decline in new patient starts for some of the company’s products.

“Due to the uncertainty related to the COVID-19 impact, we expect some degree of uncertainty in quarterly revenue and earnings over the year. We currently expect that we will see the greatest impact later in Q2, with stabilization and then partial recovery occurring during the second half of the year,” said Peter Griffith, executive vice president and chief financial officer, during the company’s 

Amgen’s Neulasta (pegfilgrastim) sales declined 40%, to $609 million from $1 billion in the comparable year-ago quarter. There are 3 pegfilgrastim biosimilars on the US market: Ziextenzo, Udenyca, and Fulphila, by Sandoz, Coherus BioSciences, and Mylan/Biocon, respectively. Two of those were launched in 2019.

Neupogen (filgrastim) sales dropped to $65 million in the first quarter of 2020 from $73 million in the comparable year-ago quarter, an 11% decline. Neupogen has competition on the US market from the Pfizer/Hospira product Nivestym and Sandoz’ Zarxio, both biosimilars. Zarxio has been on the market since 2015.

Amgen’s epoetin alfa product (Epogen) had total sales of $155 million in the just-ended quarter, down from $219 million a year ago, representing a 29% decline. Marketed only in the United States, Epogen faces biosimilar competition from Pfizer/Hospira’s Retacrit, which launched in 2018.

The company reported first quarter 2020 sales of $1.2 billion for Enbrel (etanercept), roughly unchanged from $1.2 billion in the year-ago quarter. Amgen has so far managed to fend off biosimilar competition for Enbrel. Both Sandoz and Samsung Bioepis have FDA approvals for etanercept biosimilars but no announced launch dates. Sandoz has unsuccessfully 

 2 key patents that expire in 2028 and 2029, respectively.

Although some of its products are seeing serious sales erosion from biosimilar competition, Amgen is pleased with its own biosimilar portfolio, said Murdo Gordon, executive vice president of global commercial operations. “We continue to see encouraging adoption rates in clinics, with hospital adoption accelerating. These biosimilars are increasingly valuable given the cost savings they provide,” he said.

The company’s bevacizumab (Mvasi) and trastuzumab (Kanjinti) biosimilars generated $234 million in global sales during the first quarter.

, Mvasi had $115 million in total sales, up 37% from the fourth quarter of 2019. Kanjinti had $119 million in total sales, up 16 percent from a year ago.

In the United States, Mvasi had $108 million in sales in the first quarter, versus $79 million in the previous quarter. Kanjinti’s US sales were $96 million, up from $79 million the previous quarter.

Additionally, the US market shares for Mvasi and Kanjini were 33% and 27%, respectively.

“We're fortunate that we were early in the United States with both Mvasi and Kanjinti and able to establish a very strong foothold in the market,” said Gordon. Mvasi and Kanjinti were launched in the United States in July 2019.

Mvasi is a biosimilar for reference Avastin (bevacizumab) and is used to treat colorectal, lung, glioblastoma, kidney, cervical, and ovarian cancer. It is also used to treat age-related macular degeneration.

Kanjinti is a monocolonal antibody used to treat patients with HER2-postive breast cancer and stomach cancer. It is a biosimilar for reference Herceptin (trastuzumab).

In total, Amgen reported revenue of $6.2 billion for the first quarter, up 11% from the year-ago comparable quarter.  Despite that success, uptake of some products, notably Xgeva (denosumab), is being affected by the pandemic, the company said. “Certain products like Xgeva may be impacted in the current environment due to disruptions in physician-patient interactions,” Gordon said.

Gordon expressed Amgen’s intentions to launch Avasola, their biosimilar for Remicade (infliximab), on the US market sometime later this year, but did not specify a date.

“That product will help strengthen what is already a strong immunotherapy portfolio for us, and will help us broaden that customer perspective,” said Gordon.

Additionally, Amgen has an FDA-approved adalimumab biosimilar (Amjevita) to AbbVie’s reference drug Humira. However, due to AbbVie’s current patent exclusivity, Amgen will have to wait until 2023 to release it on the US market.

Amjevita is marketed in Europe and earned $86 million in first quarter sales, up from $31 million in the year-ago quarter. It is the most prescribed biosimilar adalimumab in Europe.

To sum up the current status of biosimilars, Gordon said, “I do think that the biosimilar market is alive and well in the United States and functioning as you would hope free markets would.”

Amgen saw biosimilar competition eat a larger share of its innovator drug revenue but also earned some biosimilar pocket money of its own.
 