Skylar Jeremias

 for the first half of 2023, Alvotech revealed that its revenues have jumped nearly 600% year over year (YoY), rising from $3.9 million to $22.7 million during the first 6 months of 2022 and 2023, respectively.

The company attributed its increased revenues to improved sales of AVT02, a high-concentration adalimumab product, in select European markets and Canada.

As of June 30, 2023, Alvotech has cash and cash equivalents of $60.5 million, excluding $25.2 million of restricted cash. Down by $36.6 million were license and other revenue that were related to the completion of the AVT04 (ustekinumab biosimilar) main clinical program. Research and development expenses reached $99.6 million during the first 6 months of 2023, an increase from $86.9 million for the same period the year prior.

Alvotech is an Iceland-based pure-play biosimilar company that partners with other corporations, such as Advanz Pharma and Teva Pharmaceuticals. Per these agreements, Alvotech is responsible for development and manufacturing and their partner is responsible for marketing and commercialization of the products. Overall, Alvotech has 11 biosimilar products in its portfolio.

 with Advanz concerns several biosimilars, including golimumab, vedolizumab, omalizumab, candidates, and 3 undisclosed products. Alvotech’s agreement with Teva concerns the commercialization of AVT02 and AVT04. Alvotech is also 

 aflibercept, denosumab, omalizumab, and pembrolizumab candidates.

AVT02 has been approved as a biosimilar in the 27 member states of the European Union, Norway, Lichtenstein, Iceland, the United Kingdom, Switzerland, Canada, Australia, Egypt, and Saudi Arabia. Applications for approval are also under review in multiple countries, including the United States.

 from the FDA citing issues with the agency’s reinspection of Alvotech’s manufacturing facility in regard to the biologics license application for AVT02. The letter delayed Alvotech’s planned launch date for AVT02 but the company has expressed that it will resolve any issues and is continuing to pursue US approval.

AVT02 is marketed as Simlandi in some global markets and is offered in a prefilled syringe or prefilled autoinjector pen (pictured above).

Alvotech is also looking to obtain a US interchangeability designation for AVT02, which would allow the product to be dispensed at the pharmacy level in place of the reference product (Humira) or another adalimumab biosimilar without needing to first obtain permission from a provider. The goal of interchangeability is to increase patient access to biosimilars by making it faster and more convenient as well as alleviate ongoing challenges with drug shortages and supply chains.

 with Johnson & Johnson (J&J) regarding AVT04. J&J, the maker of reference ustekinumab (Stelara), alleged that Alvotech and Teva infringed on its manufacturing patents when developing AVT04. The settlement postponed Alvotech and Teva’s anticipated launch date for their biosimilar in the United States from late 2023 to February 21, 2025, at the earliest.

 as 1 of the 10 preliminary drugs chosen for Medicare price negotiation under the Inflation Reduction Act. To be eligible for the list, the drugs must be originator products that have a high likelihood of not facing generic or biosimilar competition for the next 2 years after publication of the selected drug list. New prices, as a result of the negotiation, will take effect in 2026.

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Alvotech’s revenues for the first 6 months of 2023 reached $22.7 million, a nearly 600% year-over-year increase.

Alvotech Earnings Jump Nearly 600% Year Over Year

After a busy July, August brought hope for the biosimilars industry’s future, with the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and several analyses about the health of the market.

The end of August brought the biggest news, with the 

 of the first natalizumab biosimilar, Tyruko (natalizumab-sztn). The product referencing Tysabri is the first biosimilar treatment for multiple sclerosis. The drug can also be used in the treatment of patients with Crohn disease.

Tyruko was developed by Polpharma Biologics, a Poland-based manufacturing and development company, and will be marketed globally by Sandoz as part of a 2019 commercialization agreement. The approval is the fourth FDA approval for a biosimilar in 2023.

 chosen for Medicare price negotiation under the Inflation Reduction Act (IRA) was announced, including 2 originator biologics that are expected to have biosimilar competition within the next decade: Stelara (ustekinumab) and Enbrel (etanercept). The full list included a range of drugs in the immunology, hematology, cardiology, oncology, and diabetes spaces.

To be eligible for negotiation, medications must have a high likelihood that they will not face biosimilar or generic competition in the next 2 years and have to have been on the US market for at least 9 years for small molecule drugs and 13 for biologics. Although Enbrel has 2 FDA-approved biosimilars and Stelara has a few biosimilar competitors coming down the pipeline, etanercept and ustekinumab biosimilars aren’t expected to launch until 2029 and 2025, respectively.

Biocon’s earnings report for the quarter showed a 

 in sales compared with the same quarter the previous year, which was largely attributed to the completed acquisition of Viatris’ biosimilar portfolio as well as market share growth for products marketed in the United States and European Union.

As part of the Viatris acquisition, Biocon gained the rights to biosimilar products in over 70 countries, and Biocon confirmed that its next steps are to integrate the business in North America by the end of the second quarter of fiscal year 2024.

The company collected $423 million in consolidated revenue, a 59% year-over-year increase from the same quarter the previous year. Biosimilar accounted for 57% of the revenue, generics made up 20%, and the other 23% was attributed to research services.

Similarly, STADA Arzneimittel saw double-digit growth in the first 6 months of 2023, foreshadowing 

 by year-end. Overall sales increased by 16% from the same period in 2022, reaching €2.1 billion ($2.3 billion). Earnings increased by 30% to €509 million ($555 million). STADA’s portfolio has 6 biosimilars available in several global markets, including the European Union, United Kingdom, and United States.

On the flip side, despite global increase in sales for Amjevita, Amgen’s adalimumab biosimilar, US sales for the product have 

 since its January 2023 market introduction. Overall profits for Amgen were up 6% from the second quarter of 2023 vs the same quarter in 2022, totaling $7.0 billion.

Market Analyses and Calls for Development Streamlining

A paper authored by 4 prominent voices in the biosimilar space from different pharmaceutical companies 

 on ways that biosimilar development could be streamlined without impacting clinical outcomes for patients.

The authors made several suggestions for policy changes to improve development efficiency and lower costs, including limiting clinical studies to pharmacokinetic evaluations and removing the requirement for multiple-switch studies to obtain US interchangeability designations.

, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, predicted greater adoption, accessibility, and provider acceptance of adalimumab biosimilars in the future, saying that these biosimilars have the potential to “transform” the US health care industry.

So far, the United States has welcomed 8 adalimumab biosimilars to the market in 2023, and projections have shown that biosimilars overall could generate $38.4 billion in health care savings between 2021 and 2025, half of which is expected to come from the adalimumab market.

Biosimilars Business Roundup: August 2023

Stelara (ustekinumab) and Enbrel (etanercept), 2 originator medications that will face biosimilar competition within the next decade, were among the 10 preliminary drugs chosen for Medicare price negotiation under the Inflation Reduction Act (IRA).

Stelara (reference ustekinumab) is available to patients in either prefilled vials or prefilled syringes for subcutaneous injection. The drug is used to treat patients with moderate-to-severe plaque psoriasis and psoriatic arthritis.

Insulin aspart (Fiasp, Fiasp FlexTouch, Fiasp PenFill, NovoLog, NovoLog FlexPen, NovoLog PenFill)

The IRA was signed into law by President Joe Biden in August 2022 after contentious votes in the Senate and House of Representatives. As required by the IRA, price negotiations between Medicare Part D plans and pharmaceutical companies will take place through the rest of 2023 and throughout next year, with the negotiated prices taking effect in 2026.

Price negotiations will be implemented in phases. Drugs eligible for negotiation must be high-expenditure, single-source medicines 

without generic or biosimilar competition

 for the next 2 years after publication of the selected drug list.

“The rationale for this delay is to not create financial incentives that could deter biosimilars from entering the market if, for example, a reference product (the original biological product approved by FDA against which a proposed biosimilar product is compared) is selected for negotiation and ultimately priced lower than potential competitor biosimilar products,” explained the Kaiser Family Foundation in its FAQ page on IRA price negotiation.

Although Enbrel has 2 FDA-approved biosimilars and Stelara has a few ustekinumab biosimilars coming down the pipeline, neither drug has biosimilars currently on the market. The chosen drugs must also have been on the market for over 9 years for small molecules and over 13 years for biologics.

Patients can access Enbrel (reference etanercept) in 25 mg or 50 mg prefilled syringes or as a 50 mg prefilled autoinjector pen. The drug is indicated to treat rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and polyarticular juvenile idopathic arthritis.

 in 2029 and ustekinumab biosimilars have been 

 from 2023 to 2025 after biosimilar manufacturers settled patent litigation suits with the originator manufacturer, Janssen. Additionally, while the European Union has 3 insulin aspart biosimilars on the market, the United States has none.

 of the list, the first 10 drugs accounted for about one-fifth of total Part D–covered prescription drug costs from June 1, 2022, and May 31, 2022, generating approximately $50.5 billion in costs. During the negotiation process, Medicare and the manufacturers will need to consider each drug’s clinical benefit, indication for unmet clinical need, and impact on Medicare beneficiaries.

While the negotiated prices for this initial list will take effect January 1, 2026, CMS will also select up to 15 additional drugs for which Part D negotiations will occur for 2027, up to 15 more for 2028 (including both Part B and Part D), and up to 20 more drugs for each subsequent year.

 has encountered significant pushback from the pharmaceutical industry, especially the biosimilars sector.

Additionally, the US Chamber of Commerce 

 to block the application of the program in July 2023, claiming the policy violated the First, Fifth, and Eighth Amendments. The Department of Justice 

 a month later, contending that the chamber lacked standing to file the lawsuit and that halting implementation of the program would harm the public interest. Lawsuits have also been filed by PhRMA, the pharmaceutical trade organization, as well as individual companies, including Merck and Bristol Myers Squibb.

Overall, the IRA law has 4 main pillars that will impact medicine pricing and cost sharing among stakeholders, including prescription drug inflation rebates, patient out-of-pocket caps, a redesign of Part D benefits, and lowering prices through negotiation.

 in payments to encourage the use of biosimilars went into effect, which increased the Medicare reimbursement on biosimilars from 6% of the average sales price of the reference drug in addition to the cost of the biosimilar to 8%. The boost will last until October 2027.

 on insulin products, including biosimilar and follow-on insulins, within Medicare Part D and Par B plans. A report from the HHS found that if the IRA cap was implemented in 2020 instead of 2023, Part D beneficiaries could have saved $734 million and Part B beneficiaries could have saved $27 million, averaging out to about $500 on insulin per member per year.

New prescription drug inflation rebates will require manufacturers to pay rebates if their drug prices increase faster than general inflation. This portion of the IRA was implemented in October 2022.

Stelara and Enbrel Chosen for IRA Price Negotiation

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the importance behind the FDA approval of Tyruko (natalizumab-sztn), the first neurology biosimilar and the first multiple sclerosis (MS) biosimilar to receive regulatory approval in the United States.

Tyruko was developed by Polpharma Biologics and will be marketed globally by Sandoz. The approval marks the fourth FDA approval for a biosimilar in 2023, following 

 (adalimumab-aaty), the autoinjector version of 

 (pegfilgrastim-cbqv), and the high-concentration version of 

What was your reaction to the FDA approval of the first neurology biosimilar, Tyruko, and why is this approval so important?

This is a really exciting approval. We have not had an approval in the neurology space [before]. This is a natalizumab biosimilar for relapsing forms of multiple sclerosis. It is extremely exciting because MS is such a debilitating disease. It's a very, very difficult disease to treat. These patients have many unmet needs, still, even with the number of treatments on the market today. There's still no perfect treatment for these patients.

So again, adding choices so that those patients can have more opportunity to potentially have a better experience with the biosimilar [or] maybe they see direct cost savings from the biosimilar. But I do think that choice [and] competition open the market to more treatment options for physicians and more options for patients as well.

This biosimilar is extremely big news. I know there's so much focus on the adalimumab biosimilars right now but introducing a brand new therapeutic area, with neurology and a biosimilar, is very, very exciting. And I'm really excited that the manufacturer [will be] able to bring this product to market and get FDA approval for this product. I'm really looking forward to it coming to market and providing more options for patients.

Videos

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, shares her reaction to the FDA approval of Tyruko (natalizumab-sztn), the first biosimilar approved to treat multiple sclerosis (MS).

Cardinal Health's Dr Fran Gregory Reacts to First MS Biosimilar Approval

Biosimilars referencing Humira (adalimumab), Remicade (infliximab), and Enbrel (etanercept) were found to have comparable safety and efficacy compared with their originator products in the treatment of rheumatoid arthritis (RA), according to a recent meta-analysis and systematic review.

, sought to fill the gap of systematic reviews for demonstrating equivalence between RA biosimilars and originators. Previous reviews provide only qualitative summaries, which may not be sufficient for providers looking to use the data in decision-making. Also, the few reviews that use quantitative evidence did not use appropriate equivalence testing methods, leading to indefinite conclusions.

Biosimilars are biologic drugs that have no clinically

meaningful differences from their reference biologics.

“As opposed to previous reviews, our review shows up-to-date conclusive evidence on the equivalence between biosimilars and their reference biologics….. Overall, our results are in line with the conclusions that both biosimilars and reference biologics are equally valuable for RA treatment,” wrote the authors.

The researchers searched MEDLINE by PubMed, Embase, Cochrane Central Register of Controlled Trials, and LILACS through September 2021 for head-to-head randomized controlled trials (RCTs) assessing adalimumab, etanercept, or infliximab biosimilars and their reference products for RA. Two authors abstracted all data independently. The meta-analysis utilized Bayesian random effects using relative risks (RRs) for binary outcomes and standardized mean differences (SMDs) for continuous outcomes.

Clinical equivalence was tested using prespecified margins outlined by the American College of Rheumatology criteria (at least 20% improvement in the core set measures [ACR20]) as well as the heath Assessment Questionnaire-Disability Index (HAQ-DI). The secondary outcomes were 14 items used to assess safety and immunogenicity.

Overall, 25 trials containing data on 10,642 randomized patients with moderate to severe RA were included in the analysis. The median sample size of the included trials was 426 patients with RA, the median (IQR) baseline age was 53 (51-54) years, and the median percentage of women was 81% (80%-84%). Adalimumab products were assessed in 11 trials (44.0%) and infliximab and etanercept products were evaluated in 7 trials each (28.0%).

Among the trials, 24 had data showing equivalence between biosimilars and reference products in terms of ACR20 response (n = 10,259; RR, 1.01; 95% CI, 0.98-1.04). Additionally, 14 RCTs demonstrated equivalence between products in terms of change of HAQ-DI scores (n = 5579; SMD, –0.04; 95% CI, –0.11 to 0.02).

Biosimilars were associated with similar rates of serious adverse events (AEs), treatment discontinuation, hypersensitivity, and positive neutralizing antibodies (ADAs). However, the risk of treatment emergent AEs (TEAEs)—including risk of injection site reaction and the formation of ADAs—were lower in patients who were treated with a biosimilar than those treated with an originator. Overall, 35.9% of patients using a biosimilar and 39.6% of those receiving the originator experienced at least 1 TEAE. Similarly, 30.0% of patients receiving the biosimilar and 33.5% of patients receiving the originator tested positive for ADAs.

To the authors' knowledge, this is the largest systematic review to assess the equivalence of RA biosimilars and originators. The review had some limitations, including the lack of generalizability outside of the molecules assessed, sparce safety data, and the detection of funnel plot asymmetry for ACR20 and implemented secondary analyses to address potential biases due to the small nature of the studies.

The authors concluded, “Further research is warranted to investigate the best strategies to address publication and small-study bias in meta-analyses involving equivalence or noninferiority trials.”

Ascef BO, Almeida MO, Medeiros-Ribeiro AC, Oliveira de Andrade DC, Oliveira Junior HA, de Soárez PC. Therapeutic equivalence of biosimilar and reference biologic drugs in rheumatoid arthritis: a systematic review and meta-analysis. 

. 2023;6(5):e2315872. doi:10.1001/jamanetworkopen.2023.15872

A meta-analysis and systematic review of data on over 10,000 patients with rheumatoid arthritis (RA) found that etanercept, adalimumab, and infliximab biosimilars were clinically equivalent to their reference products.

Meta-Analysis Confirms Clinical Equivalence Between RA Biosimilars, Originators

The FDA approved Tyruko (natalizumab-sztn), a natalizumab biosimilar, as a monotherapy for multiple sclerosis (MS), making it the first neurology biosimilar to receive regulatory approval in the United States.

 and will be marketed by Sandoz as a part of a commercialization agreement. Tyruko was approved for all indications of the reference product (Tysabri). Natalizumab is an anti- integrin monoclonal antibody disease-modifying treatment and can be used to treat clinically isolated syndrome, relapsing-remitting MS, active secondary progressive disease, and Crohn disease in adults.

As part of a 2019 agreement with Polpharma Biologics, Sandoz has exclusive commercialization rights to Tyruko in all global markets.

The biosimilar also has the same intravenous dosage form, route of administration, dosing regimen, and presentation as the reference product.

“Of the nearly one million people in the US living with multiple sclerosis, hundreds of thousands experience disease relapse. Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market,”  Keren Haruvi, president North America, Sandoz, said in a 

 a biologics license application for Tyruko in 2022 and announced its 

 a natalizumab biosimilar in September 2019. Under the global commercialization agreement for Tyruko, Polpharma Biologics will maintain responsibility for development, manufacturing, and supply of the active substance in Tyruko, and Sandoz has the rights to commercialize and distribute it in all markets.

, Polpharma Biologics began its phase 3 clinical trial assessing the safety and efficacy of Tyruko, then known as PB006, compared with the reference agent.

Polpharma published the results showing the biosimilarity between the products in 

. The parallel-group, randomized, active-controlled Antelope trial included patients from 48 centers across 7 countries, and the results supported the use of PB006 as an adequate alternative to the reference product.

In addition to Tyruko being the first and only biosimilar approved to treat relapsing forms of MS, there are no MS biosimilars approved in the European Union, Canada, or Australia. In 

, IQVIA released a report that found that neurologists in Europe are well aware of the biosimilar pipeline for MS and are planning to use them to expand treatment access for their patients.

The main generic and biosimilar drugs for MS expected to launch over the next 5 years are estimated to generate between €4.5 billion to €5.5 billion in savings between 2023 and 2028 in France, Germany, Italy, Spain, and the United Kingdom.

“Access to affordable, high-quality health care is essential for people with multiple sclerosis to live their best lives. The approval of Tyruko, the first FDA-approved biosimilar disease-modifying treatment for people with relapsing forms of MS, is a milestone. Biosimilars are an important treatment option because they have no clinically meaningful differences from their reference medicines. Prescribing them can increase accessibility to affordable medications, improve adherence and help contain healthcare costs,” Bari Talente, executive vice president for advocacy and health care access at the National MS Society, said in the statement.

The FDA approved its first biosimilar indicated for multiple sclerosis (MS), Sandoz’ Tyruko (natalizumab-sztn), a biosimilar referencing Tysabi (natalizumab).

FDA Approves First MS Biosimilar

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, 

 her opinions on the future of biosimilars in the United States, foreshadowing greater adoption, accessibility, and provider acceptance as well as a transformation of the US health care industry.

Payers, patients, and employers are eager for more biosimilar competition in the adalimumab space, which welcomed 8 biosimilar competitors since January 2023, with 1 FDA-approved product left to launch (Abrilada). Of the $38.4 billon in projected health care savings during 2021-2025 that is projected due to biosimilar competition, over half of that is expected to come from biosimilars referencing Humira (adalimumab).

However, Gregory stressed that how quickly projected savings are realized will depend on multiple factors, including pharmacy benefit managers (PBMs) and payer pricing strategies, formulary coverage, biosimilar pricing, and provider willingness to prescribe these products.

Cardinal Health’s 2023 Biosimilars Report showcased that providers’ willingness to prescribe biosimilars vary by specialty and condition, with gastroenterologists being much more willing to prescribe adalimumab biosimilars compared with rheumatologists and dermatologists.

“At Cardinal Health, we are committed to changing these perceptions. By providing education to prescribers, partnering with payers to optimize acceptance, working to educate broadly through webinars and continuing education for healthcare professionals, and engaging in initiatives to keep the provider community aware of the pipeline, we continue to make progress in biosimilar awareness and confidence,” commented Gregory.

Interchangeability is also expected to play a role. Currently, only 1 adalimumab biosimilar (Cyltezo) has an interchangeability designation, with 4 other candidates expected to gain approval for it in the next couple years. Cyltezo has been well-favored by PBMs, with 

 all announcing they will add the product to formulary.

However, while this does bode well for Cyltezo, other adalimumab products may not see the same benefits, especially since Cardinal Health’s report found at over 60% providers only felt comfortable prescribing an adalimumab biosimilar that is interchangeable.

“There have been many studies to evaluate the safety of switching to a biosimilar from a reference biologic. To date, none have found differences in safety, efficacy or the likelihood a drug will trigger an unwanted immune response. The same holds true for studies focused specifically on Humira and its alternative…. Cardinal Health will continue to help educate providers by sharing peer-reviewed literature supporting the safety, efficacy and cost-effectiveness of biosimilars,” said Gregory.

A further complication preventing adalimumab biosimilar adoption will be the 

, which can vary in concentration, citrate content, administration devices, and coverage options.

As adoption of biosimilars increase, they can impact patient accessibility to standard of care products for many chronic and life-threatening conditions as well as mitigate prescription drug spending, according to Gregory. However, to achieve the benefits, stakeholders across the health care industry will need to recognize and work to remove adoption barriers. Adalimumab biosimilars present an opportunity to better adoption strategies that allow for patients to have better clinical outcomes and less out-of-pocket costs.

Gregory concluded, “These are exciting times in the biosimilars space. As more biosimilars become available for even more life-threatening conditions, it’s easy to see a world where there will be more access to these medications at more affordable prices. When I think of the work that Cardinal Health is doing in this space, I only see positive change and growth as we continue to collaborate and accelerate the adoption of biosimilars and help improve the lives of patients.”

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, published her opinions on the future of biosimilars in the United States, foreshadowing immense growth and a transformation of the US health care industry thanks to biosimilars.

Cardinal Health Exec: How Adalimumab Biosimilars Can Reshape the US Health Care Industry 

With US' market experience with biosimilars approaching a decade, industry experts are beginning to look into ways to accelerate biosimilar development to make more lower-cost products available to patients quicker. Strict regulatory guidelines require manufacturers to conduct numerous expensive and time-consuming preclinical and clinical trials to obtain approval and prove that biosimilars are safe and effective. However, research has shown that not all of these tests may be necessary anymore and there's might be ways to cut down on development spend without compromising safety.

A commentary paper written by 4 representatives from pharmaceutical companies sought to provide an unbiased perspective on this objective can be achieved, noting that extensive testing was needed when biosimilars were new but approval requirements should be updated as the industry gains new information.

Today, I'm joined by Julie Reed, executive director of the Biosimilars Forum, a nonprofit organization aimed at the advancement of biosimilar adoption through collaboration with biosimilar manufacturers. The companies that the paper's authors represent (Samsung Bioepis, Sandoz, Boehringer Ingelheim, and Fresenius Kabi) are all members of the Forum and our discussion with Reed will highlight some of the major pieces from the paper and next steps for the industry to propel biosimilar development into the future.

To register for the FDA's workshop on streamlining biosimilar development, 

To learn more about the Biosimilars Forum and its members, 

To read the IQVIA report cited in the paper, 

Podcasts

On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, expanded on ways to make biosimilar development faster and cheaper without compromising on safety and efficacy and how these practices can ensure a sustainable market for the future.

How Streamlining Development Can Save the US Biosimilar Industry

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 August 14, 2023.

 with sintilimab and a bevacizumab biosimilar was cost-effective enough in patients with hepatocellular carcinoma (HCC) to warrant use of the biosimilar over the reference product (Avastin) without compromising safety or efficacy.

Number 4: A study on the stability of the adalimumab biosimilar candidate TUR01, a tumor necrosis factor-α inhibitor, found 

 of the drug substance and drug product were maintained under different temperatures.

Number 3: The Spanish Psoriasis Working Group 

 on the use of biosimilar medicines in patients with moderate to severe psoriasis, including its views on biosimilars as first-line treatment and nonmedical switching.

Number 2: Ranibizumab biosimilar was found to be the 

 for neovascular age-related macular degeneration (nAMD), according to a recent Japanese study.

Number 1: Robert Zutaut, RPh, a clinical specialist from McKesson Provider Solutions, quantified the major 

 for biosimilars used to treat rheumatoid arthritis (RA) and some considerations for health systems looking to address them.

To read all of these articles and more, visit 

The Top 5 Biosimilar Articles for the Week of August 14

Biocon’s earnings report for the first quarter of fiscal year 2024 (Q1FY24) showed 

 for the company’s biosimilars, which accumulated a 106% rise in sales compared with the same quarter in FY23.

The growth in biosimilar sales was largely attributed to the completed acquisition of Viatris’ biosimilar portfolio and growth in market share for products available in the United States and European Union, including the US launch of Hulio, 1 of 8 adalimumab biosimilars to enter the American market in 2023. As part of the 

, Biocon gained the rights to biosimilar products in over 70 countries, and Biocon confirmed that its next steps are to integrate the business in North America by the end of Q2FY24.

“Our key biosimilars are gaining traction in both US and Europe with Fulphila becoming the leading biosimilar pegfilgrastim in the US and biosimilar [insulin] glargine’s [Semglee] market share crossing the 12% mark. A higher new prescription share reflects the prescriber confidence in our portfolio and the overall improvement in the adoption of biosimilars,” commented Kiran Mazumdar-Shaw, executive chairperson at Biocon and Biocon Biologics, Biocon’s biosimilars business.

Overall, for the quarter, Biocon collected Rs 3516 Crore (US $423 million) in consolidated revenue, a 59% year-over-year increase from the same quarter the previous year. Core earnings for the quarter also rose 42% to Rs 936 Crore (US $112 million). Biosimilar accounted for 57% of the revenue, generics made up 20%, and the other 23% was attributed to research services.

Biosimilars alone acquired Rs 2015 Crore (US $242 million), more than double amount accumulated in Q1FY23 (Rs 977 Crore; US $117 million). Quarterly revenues for generics rose from Rs 607 Crore (US $73 million) in Q1FY23 to Rs 700 Crore (US $84 million) in Q1FY24, a 15% increase.

During the quarter, Biocon had 7 biosimilar product launches and 5 approvals in both advanced (North America and Europe) and emerging markets. Biocon biosimilars have been used to treat about 5.7 million patients around the world.

The company noted, “The revenues and margins for the quarter were impacted due to phasing of the tender business in emerging markets and higher rebates for [Fulphila] in the US, based on legacy contracts with select customers, which will normalize in the coming quarters.”

In North America, Fulphila has the highest market share compared with all other pegfilgrastim biosimilars, reaching 16%. Similarly, Ogivri, a trastuzumab biosimilar, has accumulated 11% market share and the branded and unbranded versions of Semglee, an insulin glargine biosimilar, together make up 12% market share. Biocon sells both a branded and unbranded version of the biosimilar to allow for marketing at different prices and easier access to pharmacy benefit manager formulary lists. Additionally, branded Semglee is indicated for 

 became the first aflibercept biosimilar to receive a positive opinion form the European Medicines Agency’s Committee for Medicinal Products for Human Use, and Biocon anticipates an official approval in the region by the end of September 2023. Furthermore, market shares for Ogivri, Hulio, Fulphila, and Abevmy (bevacizumab biosimilar) are rising throughout the European Union.

The emerging markets business was driven by a steady performance of its recombinant human insulin, insulin glargine, and trastuzumab biosimilars. Biocon products have won tender contracts in some countries in Latin America, Africa, and the Middle East.

In Biocon’s latest quarterly earnings report, the company revealed that sales for its biosimilars portfolio rose 106% compared with the same time frame the year prior.