Skylar Jeremias

Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of October 24, 2022.

 expressed a dire need for all stakeholders to work together to increase education efforts, provide clarity on safety and interchangeability, and encourage adoption of biosimilars in ophthalmology.

Number 4: A report from Cardinal Health tells that rheumatologists are 

 in biosimilars compared with 2020, showing that education efforts are effective and that rheumatologists are more willing to prescribe biosimilars to their patients.

 their ophthalmology biobetter, Susvimo, an ocular implant for ranibizumab injection, in the United States for a possible leakage issue.

Number 2: After months of pressure and calls for action, 

 the Biosimilar User Fee Act, which will allow the FDA to assess and collect fees for biosimilars for the next 5 years.

Number 1: Saskatchewan joined 5 provinces and 1 territory in implementing a 

, allowing for reference products to be switched out for biosimilars and lowering drug costs for the province’s public health plan.

To read all of these articles and more, visit 

Articles

The Top 5 Biosimilar Articles for the Week of October 24

After JSR Life Sciences launched its business unit focused on biosimilars (Similis Bio), it announced the signing of its first codevelopment and license agreement for 

 with Blau Farmacêutica, a São Paulo, Brazil–based company.

The companies said the biosimilars target indications in oncology, inflammation, and blood disorders but did not disclose what molecules they will reference. However, the biosimilars will have an addressable global market of over $42 billion, $1 billion of which is Brazil’s market. The transition will take several years.

“We launched Similis Bio as we saw the need to mitigate risk and accelerate timelines for biosimilar developers…. We are thrilled to partner with Blau as they work to launch their biosimilar business initially in North and South America. We look forward to leveraging our expertise and experience to support programs that can provide additional treatment options for some of the most debilitating diseases patients face,” said John Gabrielson, senior vice president of JSR Life Sciences and head of Similis Bio, in a statement from the companies.

Under the agreement, Similis Bio will provide Blau Farmacêutica with full processes and licensing, including cell lines, analytical data and methodologies, and upstream and downstream processes. After the tranfer is complete, Blau Farmacêutica will be responsible for the domestic development and seeking regulatory approval in Latin American markets.

According to the companies, the launch of the drugs is a big milestone for Blau Farmacêutica and Brazil, which has a local producer for developing and producing active pharmaceutical ingredients (APIs) and biosimilar medicines in line with the Brazilian policies regarding independent production of APIs.

“This initiative will give the world population greater access to advanced medicines, raising the standard of care…. We are developing products for the next decade, and we will further add new products to our partnership. This strategic and disruptive agreement reinforces Blau's position in becoming a reference in the production of biosimilars in Latin America,” said Roberto Morais, executive director in charge of mergers and acquisitions and strategic alliances at Blau Farmacêutica.

 and 7 more under review with ANVISA (The Brazilian Health Regulatory Agency), Brazil’s regulatory agency. 

, Celltrion Healthcare announced that it will enter the Brazilian biosimilar market, and 

, the company won a 3-year tender contract for its infliximab biosimilar (Remsima). Additionally, Bio-Thera Solutions announced that it would bring a bevacizumab candidate to Brazil in 

. Samsung Bioepis expressed interest in entering the breast cancer and gastrointestinal markets in Brazil in 

 and it launched a biosimilar referencing Enbrel (etanercept) in 

Similis Bio signed a licensing and codevelopment agreement with Blau Farmacêutica, allowing the latter to have exclusive development and marketing rights to 4 biosimilar assets in Latin America.

Similis Bio Makes Its First Licensing Deal for 4 Biosimilars in Latin America

A panel of experts in the ophthalmology and biosimilars fields expressed the need for more collaboration between stakeholders in these spaces to encourage the use of ophthalmology biosimilars.

“We do believe that this endeavor is beyond the acts of a single company. It's going to take an industry; it's going to take advocacy groups. It's going to take all of us to make a change in today's adoption of biosimilars in the US healthcare space,” said Tom Newcomer, vice president and head of market access at Samsung Bioepis, who provided an introduction and background during the event.

In Sight: The Future of Biosimilars in Ophthalmology Care

” was held as a live digital forum on LinkedIn and was sponsored by Samsung Bioepis. The discussion was moderated by Alex Brill, senior fellow at the American Enterprise Institute, and was held on October 21, 2022.

The event comes after the first 2 ophthalmology biosimilars, Samsung Bioepis’ 

 (ranibizumab-runa) and Coherus Biosciences’ 

 (ranibizumab-eqrn), entered the market in June 2022 and October 2022, respectively.

Confusion on Cimerli and Interchangeability

The event began with Sarah Yim, MD, director of the FDA’s Office of Therapeutic and Biologics and Biosimilars, who discussed the process behind how Cimerli obtained an interchangeability designation from the FDA, despite the product only being offered under the medical benefit, which has caused 

: the company’s request for the product to be reviewed for interchangeability and the route of administration. Based on the specific immunogenicity risks associated with ranibizumab injection, the FDA concluded that direct intraretinal administration by a health care provider was safe enough that Coherus did not need to submit switching study data, which is typically required for the FDA to grant interchangeability to a biosimilar.

Seenu Hariprasad, MD, interim chair and professor of ophthalmology and visual science at the University of Chicago Medicine, shared that his ophthalmologist colleagues are calling for clarity on interchangeability for retinal medications.

“The question that remains is that these are buy-and-build drugs that we use in our office. We don't go to CVS [or] Walgreens to obtain these drugs. They're administered in our office. So, how is interchangeability…relevant?.... Why even have this discussion in a retina practice when [interchangeability] is really meant to empower a pharmacist to make choices based on cost or whatever the issues are at the pharmacy level?”

Earlier this year, a report from Cardinal Health revealed that 

 are “very familiar” with biosimilars compared with over 90% of oncologists, rheumatologists, and diabetes care specialists. Also, compared with other specialists, ophthalmologists were less likely to say that they would prescribe a biosimilar.

Brian Lehman, MBA, MHA, RPh, director of patient advocacy and strategic alliances at Sandoz and alliance committee cochair at the Biosimilars Forum, explained that better education efforts directed at ophthalmology providers could help ophthalmologists feel more comfortable with ophthalmology biosimilars.

“There might be some providers out there who might be reluctant to search for educational research resources on biosimilars. So, there's a need to be proactive in terms of trying to get to providers and offer them different modalities with regards to education so they can get information that they need in their practices…. I would say it takes a village it's going to take multiple stakeholders with regards to getting that education out to the many individuals who are impacted by biosimilars,” said Lehman.

Hariprasad added that investment in education on biosimilars within ophthalmology fellowship programs is also important, especially as students can be impressionable and would likely be more open to using biosimilars. “These kids are going to be going out in the real world in just a few years…. Please, don’t forget about these young individuals in your educational programs,” he pleaded.

Tim Kane, senior vice president of rebate, trade relations, and formulary strategy at Magellan Health, expressed hope that ophthalmologists will come around as more payers feel comfortable enough to add ophthalmology biosimilars to formularies.

“On the medical side, in particular, policy management drives a lot of what happens within the overall drug category…. I think what we're seeing is the introduction of biosimilar after biosimilar in different categories is accelerating the plans acceptance of moving from an innovator to a to a biosimilar,” explained Kane.

Yim added that while she understands why ophthalmologists want to see more clinical data on biosimilars, there is a growing movement to get the FDA to stop requiring clinical data for biosimilar approval because data have shown that they may not be helpful in evaluating the safety and efficacy of these products. Yim expressed hope that eventually, ophthalmologists will join these efforts.

“I'm hopeful that we can get past that. Biosimilars have been around for long enough now that I think we can be a little bit more efficient, and we are coordinating with other countries to try and make that more feasible.”

Speakers during a LinkedIn Live panel discussion expressed a dire need for all stakeholders to work together to increase education efforts, provide clarity on safety and interchangeability, and encourage adoption of biosimilars in ophthalmology.

It’ll Take a Village: Collaborative Efforts Needed to Increase Ophthalmology Biosimilar Uptake

Genentech, a member of the Roche group, announced a voluntariy recall of Susvimo, an ocular implant for ranibizumab injection that is a biobetter for Lucentis (ranibizumab), in the United States, according to a report from 

Susvimo is an ocular implant of ranibizumab injection that is a biobetter of Lucentis (originator ranibizumab)

“The voluntary recall is based on recent testing of our commercial supply in which Susvimo implants were exposed to repeated puncturing with a needle…The results showed that some implants did not perform to our standards…. We deeply regret any disruption that this may cause to people with wet AMD and the retinal community,” Genentech explained in a statement.

 are a class of follow-on biologic products that are intentionally altered to improve clinical effects, allow for more time in between doses, or enhance tolerability.

Susvimo is used as an insertion tool for the treatment of people with neovascular age-related macular degeneration (wet AMD). Susvimo offers benefits over Lucentis in that Susvimo contains a reservoir of ranibizumab that can last for 6 months, enabling patients to require less trips to the doctor’s office over the course of a year, thereby increasing medication adherence and making it easier for patients to manage wet AMD. By contrast, regular injections of Lucentis or a ranibizumab biosimilar are required as often as once a month.

The product was approved by the FDA in October 2021. Following the approval, 2 ranibizumab biosimilars (Byooviz and Cimerli) referencing the originator (Lucentis) have enter the market, including one with an interchangeability designation (Cimerli). The approval of Susvimo 

 for biosimilar manufacturers, as many patients may be persuaded to switch from the originator to the ocular implant before patient have has the opportunity to try a biosimilar that is priced lower than both products.

4 Examples of Biobetters and the Products They're Based On

, Susvimo accumulated about $3 million in revenue over the last quarter. Additionally, Lucentis generated about $800 million in quarterly revenues, a 25% drop from the previous quarter, which the company attributed to the market introduction of Byooviz (ranibizumab-runa) at the beginning of the third quarter of 2022.

Genentech said that it has notified the FDA and is working with the agency on the recall process. It also claimed that it has taken “immediate steps to inform other health authorities, healthcare professionals, clinical trial investigators, and patient organizations” and it will offer support and guidance to help maintain clinical outcomes for patients. The company recommended that health care providers discuss the continuation of treatment with their patients who are treated with Susvimo and it said that it will be closely monitoring patients in line with FDA-approved label and clinical trial protocols.

Genentech and Roche have voluntarily recalled their ophthalmology biobetter, Susvimo, an ocular implant for ranibizumab injection, in the United States for a possible leakage issue.

Genentech, Roche Recall Ophthalmology Biobetter Susvimo

Rheumatologists’ familiarity and confidence in biosimilars increased by about 20% between 2020 and 2022, suggesting that provider-targeted education efforts are effective and that rheumatologists are gaining real world experience with them, according to 

Cardinal Health’s Rheumatology Insights report

The report was based on research from Cardinal Health’s web-based surveys conducted from July to August 2022 that included over 100 rheumatologists from community- and hospital-based practices across the United States.

“The promise of biosimilars rests on the twin pillars of affordability and accessibility…. However, this is only possible with the right health care delivery model and aligned incentives to ensure the value of these products are maximized. With so many biosimilars for HUMIRA (adalimumab) expected to launch beginning in 2023, our research suggests that these therapies will make quite an impact on the overall treatment paradigm for patients with rheumatic conditions,” said Sonia Oskouei, PharmD, BCMS, DPLA, vice president of biosimilars at Cardinal Health, in a 

In 2022, 76% of the surveyed rheumatologists reported being very familiar with biosimilars compared with 53% in 2020. Similarly, 62% of rheumatologists in 2022 said that they felt very comfortable prescribing a biosimilar to their patients vs 41% in 2020.

Regarding perception around biosimilars, 64% of respondents expressed that they feel that biosimilars positively impact rheumatology care and 47% said that they are excited about the growing number of biosimilars coming to the rheumatology space. Additionally, 85% said that patient education on biosimilars is important, and 96% said that they feel at least somewhat comfortable discussing biosimilar options with patients.

Interestingly, as the United States prepares for the market introduction of adalimumab biosimilars, 85% of respondents indicated they are at least somewhat comfortable with prescribing an adalimumab biosimilar once they become available.

Respondents reported that patient out-of-pocket cost is the key decision criteria for utilizing an adalimumab biosimilar, followed by clinical and/or real-world evidence studies and pharmacy benefit managers/payer coverage.

Opinions on whether the economics of biosimilars are favorable enough to motivate doctors to switch patients from an originator to a biosimilar have also shifted. The amount of respondents who disagreed with the statement “Today, the economics of biosimilars are not favorable enough to motivate me to switch from the reference product,” grew from 6% in 2020 to 15% in 2022. However, 54% still answered “agree” or “strongly agree.”

Confidence around the use of janus kinase (JAK) inhibitors wavered a bit in light of the FDA placing black box warnings on these products. Prior to the FDA warnings, 78% of respondents were prescribing them “often” or “very often.” After the warnings, 14% said that they would be “very likely” to prescribe a JAK inhibitor and 58% said “likely.”

Finally, supply chain disruptions was noted as a big concern for rheumatologists, with 85% saying that disruptions have had an impact on their treatment decisions and they have had to adapt to several strategies to handle them. Overall, 60% reported having to make medication substitutions, 43% said that they switched patients to a different mediation, and 16% reported delaying a patient’s therapy.

Rheumatology insights: October 2022. Cardinal Health. October 19, 2022. Accessed October 20, 2022. 

https://www.cardinalhealth.com/en/cmp/ext/phr/specialty-pharma/rheumatology-insights.html

A report from Cardinal Health tells that rheumatologists are more familiar and confident in biosimilars compared with 2020, showing that education efforts are effective and that rheumatologists are more willing to prescribe biosimilars to their patients.

Cardinal Health Reports Increased Confidence in Biosimilars Among Rheumatologists

Here are the top 5 biosimilar articles for the week of October 17, 2022.

Number 5: St John Skilton, PhD, vice president of product strategy and marketing at Protein Metrics, takes a deep dive into how the development of biosimilars is evolving and how tools, such as mass spectrometry, can 

Number 4: Bio-Thera Solutions began a phase 1 trial for its 

 candidate; Biocon Biologics licenses out 2 biosimilars to Yoshindo; and Alvotech and STADA Arzneimittel launch Hukyndra, an adalimumab biosimilar, in Switzerland.

Number 3: Biosimilars Canada, a national association representing the Canadian biosimilar industry, held a press conference 

, the province containing the nation’s capital, to institute a biosimilars switching policy.

 explores the evolution of the US biosimilar industry, including current trends, predictions for the next few years, advice for stakeholders going forward, and insight into how reimbursement and other policies could develop.

Number 1: A study from the Republic of Korea confirmed the safety and efficacy of 

 in patients with heavily pretreated human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.

Videos

The Top 5 Biosimilar Articles for the Week of October 17

The Saskatchewan Ministry of Health announced that it will 

 policy, making it the sixth Canadian province and seventh jurisdiction to do so. Saskatchewan joins 

“This initiative will ensure access to high-quality, essential medications for Saskatchewan residents remains sustainable into the future…. The savings will be reinvested into the Saskatchewan Drug Plan to support patient access to public drug coverage and new drug benefits,” Paul Merriman, health minister of Saskatchewan, commented.

John Esdaile, MD, scientific director of Arthritis Research Canada applauded BC’s program and its transition plan, saying that it could ease Saskatchewan citizens who may be worried about their prescriptions changing.

“Having successfully gone through the transition process with patients in BC starting in 2019, patients and providers should feel confident about the transitioning to biosimilars in Saskatchewan,” he said.

In BC, eligible patients were alerted in advance that their prescriptions would be changed to a biosimilar. The program was rolled out in multiple phases, which each progression adding more originators to the list of biologics that would no longer be covered by the province’s public health plan.

Biosimilars Canada, a national association representing the biosimilar industry in Canada, 

 on the measure, saying that it hopes that the remaining provinces and territories (Ontario, Manitoba, Newfoundland and Labrador, Prince Edward Island, Yukon, and Nunavut) will follow in Saskatchewan’s footsteps to implement similar policies.

According to the organization, about 24,000 patients in Saskatchewan who are being treated with an originator biologic are expected to transition to a biosimilar version over the next 6 months.

Although biologic drugs have been revolutionary in the fight to treat several chronic conditions and cancers, originator biologics can cost between $10,000 and $25,000 or more annually per patient, which can place a large financial strain on drug budgets. The Ministry of Health estimated that Saskatchewan could save $20 million once the transition period is complete.

“Biosimilars Canada congratulates Health Minister Paul Merriman and the government of Saskatchewan for implementing a biosimilar switching policy and reinvesting the savings to support patient access to public drug coverage and new drug benefits…. Expanding the use of biosimilars through a switching policy is an important way to ensure the sustainability of drug plans and make the most effective use of taxpayer dollars,” said Jim Keon, president of Biosimilars Canada.

The statement comes shortly after the advocacy group 

 calling on Doug Ford, the premier of Ontario, to put a biosimilar switching initiative in place in the province.

Patients who are covered by the Saskatchewan Drug Plan and use certain biologic drugs to treat conditions including arthritis, diabetes, inflammatory bowel disease, and psoriasis will have to switch to a biosimilar version of their medicine by April 30, 2023. Canada currently has 49 approved biosimilars.

Saskatchewan joined 5 provinces and 1 territory in implementing a biosimilar switching policy, allowing for reference products to be switched out for biosimilars and lowering drug costs for the province’s public health plan.

Saskatchewan Becomes Sixth Canadian Province to Implement a Biosimilar Switching Policy

By signing the FDA User Fee Reauthorization Act of 2022, President Biden also 

 the Biosimilar User Fee Act, also known as BsUFA III. The reauthorization will enable the FDA to assess and collect fees for biosimilars from October 2022 to September 2027.

“The new law ensures that FDA will continue to receive a source of stable and consistent funding during fiscal years 2023-2027…. Biosimilar biological products represent an important public health benefit, with the potential to offer life-saving or life-altering benefits at reduced cost to the patient,” the FDA commented on its website.

For several months, advocates and industry leaders have been calling on the administration to advance BsUFA III, including representatives from the 

“We are committed to developing a robust biosimilar industry in the US, and to help the BsUFA program further develop over the next five years. We are at a critical inflection point for the biosimilars industry and we believe that enhancing the process for biosimilar development, review and educating the public of the importance of biosimilars is critically important to sustaining and cementing the biosimilar pathway for years to come,” said Juliana (Julie) M. Reed, executive director of the Biosimilars Forum in an April 2022 letter to the Senate Committee on Health, Education, Labor and Pensions encouraging the progression of BsUFA III.

 to Congress in February 2022 by Representative Angie Craig (D-Minnesota). It passed in the House on March 31 and passed in the Senate on September 29 with an amendment.

When collecting user fees for biosimilars, the FDA applies them to “expediting the process for the review of biosimilar biological product applications, including postmarket safety activities.” 

, BsUFA assists biosimilar development and expedites the development process to get these products to the American public sooner.

The original BsUFA became law in 2012 and it was last reauthorized in 2017. Between March 2021 and June 2021, the FDA developed the changes for BsUFA III through collaboration with drug industry representatives. In November 2021, the FDA held a virtual 

BsUFA III Reauthorization Proposed Enhancements Public Meeting

, during which members of the public were invited to hear opening remarks, background on BsUFA III, and overview of recommendations for reauthorization, industry perspectives, and public comment. A similar meeting also occurred in November 2020. The enhancements that FDA developed as a result of these meetings and consultations were referred to Congress in January 2022 as part of Title IV of the FDA User Fee Reauthorization Act.

The FDA released a commitment letter for BsUFA III that outlined the performance goals and procedures for the act for the next 5 years. The letter highlighted the FDA’s commitment to using BsUFA III to:

Ensure the effectiveness of the Biosimilar Biological Product Review Program

Enhancing the development of biosimilars and interchangeable products

Continuing to enhance user fee resource management

Improve FDA hiring and retention of review staff

Monitor and modernize data collection and technological tools for biosimilar development

After months of pressure and calls for action, President Biden reauthorized the Biosimilar User Fee Act, which will allow the FDA to assess and collect fees for biosimilars for the next 5 years.

Biden Authorizes Update to the Biosimilar User Fee Act Through 2027

, giving an extensive look at the current state of the market for biosimilars, which the company says has driven $21 billion in savings over the past 6 years.

 by the FDA and 24 have launched. Overall, the average sales price (ASP) of reference products and biosimilars is dropping. The prices have gone down at a negative compound annual growth rate of -9% to -24% for biosimilars and -4% to -21% for originators. In addition, biosimilars have an average of 75% market share if they launched during 2019 and 39% share during the first 3 years if they launched before 2019.

The report predicted a greater expansion of biosimilars in the pharmacy benefit space, biosimilars in more therapeutic classes, and more approvals and launches for interchangeable biosimilars. Additionally, the report noted some of the biggest regulatory policies that have impacted biosimilars in 2022, including the passage of the 

“We anticipate biosimilars in 2022 to continue the promise of cost savings to have the potential to increase access to patients. This year will prove pivotal for the pharmacy benefit space, as providers and pharmacists navigate the first interchangeable biosimilar insulin listed as preferred on several national formularies,” said Beth McMahon, senior vice president of emerging therapies and channel strategy at AmerisourceBergen, in the report.

In addition to more legislation and more biosimilars, the number of development programs that are participating in the FDA’s Biosimilar Development Program has risen from 77 programs in March 2019 to 96 programs in March 2022, despite a slow increase in 2020 as a result of the COVID-19 pandemic.

Biosimilars in the medical benefit typically launched at a wholesale acquisition cost (WAC) that is between 10% and 57% lower than the WAC of the originator.

The report noted the successful uptake of oncology biosimilars, which account for nearly 80% market share in the trastuzumab and bevacizumab markets and 64% of the rituximab market share. Despite biologics representing half of the therapies used in treating cancer, the high cost associated with them results in much greater costs in development and production compared to small molecule drugs.

“The price takes its own toll on cancer patients with [more] patients facing out-of-pocket costs. It becomes hard for them to sustain the level of cancer care. I think biosimilars definitely help assimilate some of that kind of challenge,” said Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care.

Trastuzumab biosimilars have led to a 19% price drop in the reference product (Herceptin) and bevacizumab biosimilars have resulted in a 15% decline in Avastin’s (reference bevacizumab) price. Rituximab biosimilars have led to an 11% drop in the ASP of Rituxan (reference rituximab) and are priced between 51% and 56% lower than the reference product.

Additionally, biosimilars account for 42% of the pegfilgrastim market and generated $724 million in savings by the second quarter of 2022 (Q2 2022). Filgrastim biosimilars are also priced between 60% and 81% lower than the reference product (Neupogen) and account for 82% of all filgrastim products.

The presence of 1 epoetin alfa biosimilar has resulted in significant price declines for the biosimilar and the reference product (Epogen/Procrit), both experiencing over a 30% decrease from the ASP of the reference product in the fourth quarter of 2018, when the biosimilar launched.

Infliximab biosimilars have experienced a tougher adoption journey. Although the ASP of the originator Remicade has dropped 57% since the onset of biosimilar competition, infliximab biosimilars still trail behind the reference product in market share (42% vs 54%, respectively). However, infliximab biosimilars have still resulted in $660 million in savings in Q2 2022.

Amgen’s ninth edition of its Biosimilar Trends Report explores the evolution of the US biosimilar industry, including current trends, predictions for the next few years, advice for stakeholders going forward, and insight into how reimbursement and other policies could develop.

Amgen Report: Biosimilars Have Saved $21 Billion in 6 Years

Bio-Thera Solutions began a phase 1 trial for its mepolizumab biosimilar candidate; Biocon Biologics licenses out 2 biosimilars to Yoshindo; and Alvotech and STADA Arzneimittel launch Hukyndra, an adalimumab biosimilar, in Switzerland.

Testing for Mepolizumab Biosimilar Begins

 for a biosimilar candidate referencing Nucala (mepolizumab). The study would assess the pharmacokinetics and safety of the biosimilar (BAT2606) in healthy participants.

The randomized, double-blind, parallel group, single-dose study will include 207 healthy volunteers. Mepolizumab is an interleukin 5 antagonist monoclonal antibody that can be administered subcutaneously with a syringe or autoinjector device. Nucala is used to treat:

Adult and pediatric patients 6 years and older with severe asthma or an eosinophilic phenotype as an add-on maintenance therapy

Adult patients with chronic rhinosinusitis with nasal polyps as an add-on maintenance therapy

Adult patients with eosinophilic granulomatosis with polyangiitis

Adult and pediatric patients 12 years and older with hypereosinophilic syndrome for at least 6 months without a nonhematologic secondary cause

After the study is completed, Bio-Thera will conduct a global phase 3 study. The company said that it plans to apply for regulatory approval in the United States, China, the European Union, and other markets around the world.

Biocon Biologics Licenses Out to Yoshindo

Biocon Biologics entered into a licensing agreement with Yoshindo for the Japanese commercialization of 2 biosimilar candidates: an ustekinumab biosimilar and a denosumab biosimilar.

Under the deal’s terms, Yoshindo would have exclusive commercialization rights for the biosimilars in Japan in exchange for $700 million. Biocon Biologics would receive an upfront license fee along with additional payments dependent on the achievement of development milestones over the next few years. The companies did not disclose the exact financial terms of the deal.

The ustekinumab biosimilar references Stelara and will be used to treat autoimmune conditions including, psoriasis, Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The denosumab candidate references Prolia and is used to treat patients with osteoporosis and patients undergoing cancer treatments who are at a high risk of fracture. Phase 1 and phase 3 clinical trials for the biosimilars began in 2022.

“Once approved, these products will expand our offering of affordable, high quality biosimilars in the Japanese market and help address unmet patient needs in bone health and immunology therapy areas,” said Shreehas Tambe, deputy CEO of Biocon Biologics, in a 

Alvotech and STADA Arzneimittel announced that they 

, an adalimumab biosimilar referencing Humira, in Switzerland. Hukyndra launched as a high-concentration, low-volume, citrate-free formulation.

“Significant unmet needs for access to biologics exist for patients across Europe…. Our partnership with Alvotech enables STADA to deliver a broad range of high-quality biosimilars to European patients. Launches of Hukyndra in multiple markets is evidence of our commitment to broader access to critical therapies,” said Bryan Kim, head of global specialty and executive vice president of STADA.

STADA and Alvotech entered into their partnership in November 2019. The agreement includes 7 biosimilars, including Hukyndra. Alvotech is responsible for development and manufacturing and STADA is in charge of commercialization. In Switzerland, Hukyndra is being marketed by Spirig HealthCare, a subsidiary of STADA. The biosimilar will be made available in 80 mg/0.8mL and 40 mg/0.4 mL syringes for self-administration and 40 mg/0.4 mL prefilled autoinjector pens.

The European Medicines Agency granted Hukyndra marketing authorization in November 2021. In addition to Switzerland, Hukyndra 

 in Austria, Estonia, France, Finland, Germany, Lithuania, Slovakia, and Sweden. The biosimilar has also been approved in the United Kingdom and is 