Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

Skylar Jeremias

The FDA has accepted a biologics license application (BLA) for Alvotech’s ustekinumab biosimilar candidate (AVT04) referencing Stelara, which will be used to treat several autoimmune disorders, according to a 

“The progress of AVT04 helps to validate the end-to-end biosimilars development and manufacturing platform that we have built at Alvotech…. Our approach is multi-product, and we look forward to broadening our portfolio as we continue to focus on expanding access to affordable biologic medicines,” said Joseph McClellan, chief scientific officer of Alvotech.

Ustekinumab products are monoclonal antibodies that act as inhibitors for interleukin (IL)-12 and IL-23. Stelara, developed by Janssen Pharmaceuticals, is indicated for the treatment of patients with psoriatic arthritis, plaque psoriasis, and inflammatory bowel disease, which is an umbrella term for ulcerative colitis and Crohn disease.

Alvotech has a commercialization partnership with Teva Pharmaceuticals, which will have exclusive rights to marketing AVT04 in the United States if it is approved. The companies anticipate the FDA’s final decision on AVT04 to come in the second half of 2023.

“We are pleased to be one step closer to making AVT04 available to patients and providers as a biosimilar treatment option to Stelara® for indicated inflammatory conditions…. Teva continues to remain focused on our commitment to lower healthcare costs and expand the availability and access of biosimilars,” commented Christine Baeder, senior vice president and chief operating officer of US Generics at Teva.

Alvotech and Teva’s partnership began in August 2020 and concerns 5 biosimilar candidates, including an adalimumab biosimilar (AVT02) referencing Humira. AVT02 is currently under review with the FDA and is expected to enter the US market in July 2022, along with 6 other adalimumab biosimilars.

 the clinical safety and efficacy of AVT04 compared to the reference product in patients with moderate to severe chronic plaque psoriasis as well as 

 from a phase 1 pharmacokinetic equivalence study.

The news comes after Janssen, a division of Johnson & Johnson and the owner of Stelara, 

 over its ustekinumab biosimilar candidate. Janssen claimed that Amgen infringed on 2 of its patents when creating the biosimilar.

In addition to Alvotech and Amgen, California-based Rani Therapeutics is in the preclinical development staged for RT-111, a RaniPill Go capsule to administer an ustekinumab biosimilar. The RaniPill capsule would allow for 

 with Yoshindo for the commercialization of its ustekinumab biosimilar in Japan in October 2022. Formycon published positive 

 for its ustekinumab biosimilar, for which the company 

. Bio-Thera and Hikma Pharmaceuticals have also partnered to compete against Stelara with a biosimilar (BAT2206). Hikma would be in charge of US commercialization.

Articles

Alvotech, an Iceland-based company, announced that the FDA accepted its biologics license application (BLA) for its proposed ustekinumab biosimilar referencing Stelara. The company said it expects the FDA’s decision in the second half of 2023.

FDA Accepts BLA for Alvotech Ustekinumab Biosimilar

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 January 2, 2023.

 throughout the year tended to focus on the advancements of ranibizumab biosimilars, such as the US launch of Byooviz, the recall of a biobetter of ranibizumab, and the UK approval of Ongavia.

Number 4: News surrounding biosimilars referencing Humira (adalimumab) 

 of biosimilar articles related to rheumatology in 2022, highlighting the excitement for these biosimilars to launch starting in early 2023.

Number 3: Sarfaraz K. Niazi, PhD, summarized some of the lessons that the entire biosimilar industry can 

, including what new legislation and policy changes could mean for future biosimilar development.

Number 2: A study assessing the use of tumor necrosis factor (TNF) alpha inhibitor biosimilars in France found that the biosimilar penetration rate was higher for infliximab compared to etanercept and adalimumab. The authors said they aimed to understand the 

Number 1: Health Canada has approved the 

 of Samsung Bioepis and Organon’s Hadlima, a citrate-free adalimumab biosimilar referencing Humira.

To read all of these articles and more, visit 

The Top 5 Biosimilar Articles for the Week of January 2

Celltrion Healthcare announced its submission of a biologics license application (BLA) for Remsima SC, a biobetter of the company’s infliximab biosimilar (Remsima) that allows for subcutaneous administration.

 in April 2016 and launched on the US market in November 2016, where it is marketed as Inflectra through a commercialization agreement with Pfizer. It is 1 of 4 infliximab biosimilars approved in the United States.

Remsima SC can be offered in a prefilled syringe or auto-injector pen

Remsima SC (CT-P13) is the world first subcutaneous infliximab product, which can be a more convenient method of administration for patients than intravenous injection. Additionally, the biobetter has been shown to produce 

 compared with the original Remsima, according to data presented at the European Congress of Rheumatology’s annual meeting in June 2022.

The data from the phase 3 study demonstrated the safety and efficacy profiles of Remsima SC as maintenance therapy in patients with moderate to severe active ulcerative colitis (LIBERTY-UC) and Crohn disease (LIBERTY-CD). The results showed that Remsima SC had superiority over placebo in maintenance therapy after induction therapy of intravenous formulation infliximab in patients with UC and CD, respectively, over 1 year. The studies featured 438 patients with UC and 343 patients with CD. Both studies were randomized, placebo controlled, and double blinded.

“This BLA submission marks a significant milestone for Celltrion and we are working with the FDA to bring this innovative treatment to the U.S. market…. We are committed to furthering the advancement of innovative treatments that provide improvements to clinical outcomes and drug pharmacology and reduce patients’ burden on their day-to-day lives,” said Hyoung Ki Kim, vice chairman and CEO of Celltrion Healthcare, in a statement.

Biobetters 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. Although many biobetters are developed as 

, Remsima SC is unique in that it is a biobetter based on a biosimilar of Remicade (reference infliximab).

According to Celltrion, using Remsima SC can offer patients better consistency in drug exposure and allow for better drug adherence compared with intravenous administration.

“We’re excited about the potential of CT-P13 SC as it allows patients to have more control of their treatment, providing much better independence and convenience…. In addition, CT-P13 SC releases the burden of having to travel to treatment for IV infusions, reducing treatment-related travel costs for patients and caregivers,” commented Jaeik Shim, chief operating officer at Celltrion USA.

, Health Canada approved Remsima SC for the treatment of rheumatoid arthritis. The product is also approved in the Republic of Korea and the European Union.

® in August 2022, Kim said that he anticipates the FDA’s approval decision during the second half of 2023.

“Biobetters could be transformative for the biopharmaceutical space going forward—in the same way that the introduction of biologic therapies and biosimilars were….In light of advancing technologies and innovative approaches, biobetters could allow for improved patient and health care professional choice, and ready-to-use formulations such as Remsima SC could reduce the handling burden for clinicians, especially in light of the [COVID-19] pandemic.”

Celltrion Healthcare submitted a biologics license application (BLA) to the FDA for its biobetter of its infliximab biosimilar allowing for subcutaneous administration (Remsima SC).

Celltrion Submits BLA for Infliximab Biobetter 

 of its high-concentration (HC), citrate-free formulation of its biosimilar referencing Humira (adalimumab). Hadlima HC was developed through a commercialization agreement between Samsung Bioepis and Organon.

The approval comes almost 4 years after Health Canada’s initial approval of the low-concentration version of Hadlima (SB5) in May 2018. Both concentrations of Hadlima will be used in the treatment of a number of rheumatic conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn disease, ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, and uveitis.

“We are pleased to receive Health Canada approval of our high concentration adalimumab biosimilar, marking a key milestone for us now to have both a low and high concentration adalimumab biosimilar approved in Canada….The latest approval reflects our continuous efforts to meet the needs of our patients and bring more treatment options available,” commented Byoungin Jung, vice president and leader of the Regulatory Affairs Team at Samsung Bioepis, in a statement.

Health Canada’s decision on the new formulation was based on data from a phase 1 clinical trial assessing the pharmacokinetics (PK), safety, and tolerability of the new formulation (40 mg/0.4 mL) compared with the low-concentration version (40 mg/0.8 mL) in healthy male subjects. The study established equivalent PK between both versions, which were also found to be well tolerated by the participants and had similar safety profiles.

More Updates on Samsung Bioepis Biosimilars

The approval follows Samsung Bioepis’ announcing updates to its studies surrounding proposed biosimilars for Soliris (eculizumab), Prolia/Xgeva (denosumab), and Stelara (ustekinumab). The data for SB12 (eculizumab biosimilar) were shared at the American Society of Hematology Annual Meeting (ASH), which occurred at the tail end of 2022 in New Orleans, Louisiana.

The company announced the completion of phase 3 studies assessing 

 (denosumab biosimilar) compared with their originators in patients with moderate to severe plaque psoriasis and female patients with osteoporosis, respectively.

Samsung Bioepis originally published data on SB12 at the European Hematology Association Congress (EHA) in June 2022 but shared additional data at ASH 2022. The phase 3 study on SB12 demonstrated equivalent safety, PK, pharmacodynamic, and immunogenicity profiles between the biosimilar and Soliris in patients with paroxysmal nocturnal hemoglobinuria.

The primary end points were the level of lactate dehydrogenase (LDH) at week 26 and time-adjusted area of under the effect curve of LDH from week 14 to week 36 and from week 40 to week 52. The results showed that the endpoints between the biosimilar and the originator fell within the predefined equivalence margin (34.48; 95% CI, –47.66 to 116.62).

Researchers also conducted a sensitivity analysis, which showed consistent results and validated the study’s robustness, further supporting the therapeutic equivalence between the 2 drugs.

“We are fully aware that rare diseases, such as PNH pose many, but unique, challenges to patients and their families. We will continue our journey to transform the way biologic therapies are brought to patients and enhance the lives of patients, including those with rare diseases, through our pioneering and innovative use of science and technology,” said Luke Oh, PhD, vice president and product evaluation team leader at Samsung Bioepis, in a 

Health Canada has approved the high-concentration version of Samsung Bioepis and Organon’s Hadlima, a citrate-free adalimumab biosimilar referencing Humira.

Canada Approves High-Concentration Humira Biosimilar

Biosimilar news in ophthalmology throughout the year tended to focus on the advancements of ranibizumab biosimilars, such as the US launch of Byooviz, the recall of a biobetter of ranibizumab, and the UK approval of Ongavia.

5. First Ophthalmology Biosimilar Launches in US

In June, Biogen and Samsung Bioepis announced the US launch of Byooviz, the first ophthalmology biosimilars and the first ranibizumab biosimilar to receive FDA approval and launch on the US market. The drug was developed for the treatment of retinal diseases, including age-related macular degeneration (AMD), diabetic retinopathy, and macular edema. Byooviz was approved in September 2021 and has been approved in the European Union and Canada.

4. Genentech, Roche Recall Ophthalmology Biobetter Susvimo

Genentech, a member of the Roche group recalled its biobetter of Lucentis (ranibizumab), Susvimo, an ocular implant for ranibizumab injection. The recall was in reference to a possible leakage issue. Biobetters are a class of follow-on biologics that are altered to improve clinical effects, allow for more time in between doses, or enhance drug tolerability. The product was approved in October 2021 and accumulated about $3 million in revenue over the first 9 months of 2022. Susvimo offers a benefit over Lucentis by allowing patients to go up to 6 months between doses.

3. Biosimilars Check-In: Celltrion Pushes for Yuflyma in Europe; Xbrane Updates on Ranibizumab Filing

Xbrane Biopharma announced that it has received a general advice letter from the FDA regarding its biologics license application (BLA) for a ranibizumab biosimilar candidate. The company was asked to resubmit a new BLA for the biosimilar. The news came after Xbrane was asked to submit additional data following a preliminary review before the FDA could accept the application for review. Xbrane said that it plans to resubmit before the end of 2022.

2. Teva’s Lucentis Biosimilar Gains UK Approval

The UK Medicines & Healthcare Regulatory Agency approved Teva Pharmaceuticals’ Ongavia, a ranibizumab biosimilar. Ranibizumab is a vascular endothelial growth factor inhibitor to prevent excessive blood vessel formation in the retina. AMD is the leading cause of blindness in developed countries and is expected to impact up to 77 million people across Europe by 2050. The UK approval was based on data from a randomized, double-masked, parallel group, multicenter phase 3 study comparing the safety and efficacy of Ongavia with the reference product in patients with AMD.

1. Review: Biobetters and Biosimilars Set to Emerge in Ophthalmology

A literature review on the development of ophthalmology biosimilars predicted a strong market and development push for biobetters in the future. Although biobetters can provide enhanced clinical outcomes to reference biologics and biosimilars, biobetter development may require companies to make a much larger investment in development compared with biosimilars. The review went on to describe explain the appeal of products like Susvimo and forecasted the use of bevacizumab biosimilars to treat retinal conditions. It also previewed at least 8 aflibercept biosimilars referencing Eylea that are in development.

The Top 5 Ophthalmology Articles of 2022

On this episode, we’re going to review the top stories and milestones to hit the biosimilar industry this year. From the launch of a generic lenalidomide, the FDA approval of a high-concentration adalimumab biosimilar, to the launch of the first ophthalmology biosimilar. We’re also going to be recommending our top 5 podcast episodes of the year so stick around to hear more about what 2022 has in store for biosimilars around the world.

FDA Approves Stimufend, the US’ Sixth Pegfilgrastim Biosimilar

Contributor: No Animal Testing of Biosimilars—US Congress Begins Amendment to BPCIA

AbbVie Settles ITC Case With Alvotech; Humira Biosimilar to Launch July 2023

Review: Biobetters and Biosimilars Set to Emerge in Ophthalmology

Part 1: Biosimilars to Bring a Bumper Crop of Adalimumab Options

FDA Accepts BLAs Supporting Interchangeability From Alvotech, Pfizer for Biosimilars to Humira

Samsung Bioepis and Organon Seek to Enter the Market for High-Concentration Adalimumab

FDA Approves High-Concentration Formulation of Samsung Bioepis’ Humira Biosimilar

Teva Announces US Launch of Lenalidomide, Generic of Revlimid

How Health Policy Can Impact Adoption for Adalimumab Biosimilars

New Biosim on the Block: Dr Sonia Oskouei Discusses the US Launch of Byooviz, the First Ophthalmology Biosimilar

What Amgen’s Biosimilar Trends Report Says About the Future of Biosimilars

How Health Policies May Take Shape in a Post-Humira-Exclusive Adalimumab Market

What Will Year 1 Look Like for Adalimumab Biosimilars?

Podcasts

To say goodbye to 2022 and welcome in the new year, The Center for Biosimilars recaps the biggest news stories and milestones from the past 12 months as well as list of the top 5 podcast episodes of the year.

Goodbye 2022—The Top 10 Biosimilars Stories of the Year

Conferences throughout 2022 shared new information on white bagging, the safety of biosimilar substitution, the use of a biobetter, and discussion around the role that pharmacy benefit managers (PBMs) play in biosimilar adoption.

5. NCCN Panel: How White Bagging Is Tied to High Drug Costs

A panel at the National Comprehensive Cancer Network (NCCN) annual meeting explored how white bagging, where PBMs require certain high-cost drugs to be shipped from their own specialty pharmacies to practices, is connected to higher drug costs. Oftentimes, the drugs involved in this practice may not arrive at clinics fully intact or a patient may require a dose change. The panelists also expressed how white bagging raises concerns about patient safety, as drugs may be sent to the wrong address or be delayed due to weather events. One panelist shared his worries about hospital liability when issues with delivery occur, such as the growing real-world situations within the community oncology space.

4. ASCO Studies Assess Biosimilar Substitution, Adoption in Oncology Practices

At the American Society of Clinical Oncology (ASCO) annual meeting, researchers shared a poster on how biosimilar substitution led to significant reductions in aggregate provider risk in the Oncology Care Model (OCM), which suggested that continuing the practice could mitigate risks in value-based payment models for cancer. Another poster examined the financial impact of biosimilars within the OCM. Increased use of biosimilars within the US Oncology Network generated million of dollars in savings in the OCM, suggesting that continued adoption could increase savings to Medicare in the OCM.

3. Celltrion’s Infliximab Biobetter Shows Significant Clinical Improvements Over Original Biosimilar Version

Celltrion Healthcare presented new data on Remsima SC, a biobetter based on the company’s infliximab biosimilar (Remsima), at the European Congress of Rheumatology’s annual meeting. The biobetter has been specially formulated to allow for subcutaneous (SC) administration in patients with rheumatic conditions, including rheumatoid arthritis, psoriasis, and inflammatory bowel disease. The data showed that the biobetter produced better clinical outcomes, such as better remission rates and lower disease activity rates, than the original Remsima through week 54.

2. Phase 3 Data Show Celltrion’s Bevacizumab Biosimilar Is Equivalent to Avastin in Lung Cancer

Another phase 3 study on Celltrion’s bevacizumab biosimilar (CT-P16) showed an objective response rate equivalent to the reference product (Avastin) in patients with metastatic or recurrent non-small cell lung cancer. The data from the double-blind, randomized, multicenter study was presented at the American Association of Cancer Research annual meeting. The analysis examined the drugs in 689 patients, 342 of whom received the biosimilar and the other 347 received the reference product. The researchers concluded that their results demonstrated clinical equivalence to between the drugs.

1. Prior Authorization Panel Yields Insights Into Role of PBMs in Biosimilar Uptake

A session from the Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit dove into recent dynamics between PBMs and practices over uptake of biosimilars and concerns about missing out on biosimilars savings if action isn’t taken. Most of the discussion focused on how prior authorization had increased administrative burdens on practices and the panelists suggested that the quest for rebates by PBMs could impact formulary placement for biosimilars. The panelists also touched on how some PBMs abuse step edits and create challenges in the diagnostic space.

Conferences throughout 2022 shared new information on white bagging, the safety of biosimilar substitution, the use of a biobetter, and discussion around the role that pharmacy benefit managers play in biosimilar adoption.

The Top 5 Conference Articles of 2022

News surrounding biosimilars referencing Humira (adalimumab) topped the list of biosimilar articles related to rheumatology in 2022, highlighting the excitement for these biosimilars to launch in the United States starting in early 2023.

5. FDA Approves High-Concentration Formulation of Samsung Bioepis’ Humira Biosimilar

The FDA approved the high-concentration version of Hadlima, 1 of 8 adalimumab biosimilars slated to launch on the US market next year. Hadlima was developed by Samsung Bioepis through a commercialization agreement with Organon, which will market the drug. The biosimilar is one of the only adalimumab biosimilars that will be offered in a high-concentration and a low-concentration formulation. Currently, the high-concentration version of the originator makes up about 80% of all adalimumab prescriptions.

4. Samsung Bioepis and Organon Seek to Enter the Market for High-Concentration Adalimumab

In January 2022, Samsung Bioepis and Organon, a spinoff of Merck, announced that they would collaborate to bring a high-concentration adalimumab biosimilar (Hadlima) to the US market. The product is expected to launch in July 2023 along with at least 6 others. The low-concentration version of Hadlima was approved in 2019. High-concentration adalimumab allows patients to receive fewer doses of adalimumab compared with a low-concentration version. The citrate-free aspect reduces pain for patients undergoing adalimumab therapy.

3. FDA Accepts BLAs Supporting Interchangeability From Alvotech, Pfizer for Biosimilars to Humira

The FDA accepted biologics license applications (BLAs) from Alvotech and Pfizer requesting for their respective adalimumab biosimilars to have interchangeability designations in the United States. The FDA set a goal decision date of December 2022 and both biosimilars (AVT02 and Abrilada) are expected to launch in July 2023. Pfizer’s Abrilada was approved in November 2019 and Alvotech’s AVT02 is being reviewed by the FDA.

2. AbbVie Settles ITC Case With Alvotech; Humira Biosimilar to Launch July 2023

AbbVie settled its outstanding lawsuits, including a case related to the International Trade Commission (ITC), with Alvotech, allowing Alvotech to launch its high-concentration, citrate-free adalimumab biosimilar in July 2023 once it’s approved. The settlement fully resolved all pending US disputes between the companies. In the ITC case, AbbVie alleged that Alvotech developed AVT02 through theft of trade secrets. The agreement removed any remaining litigation barriers keeping AVT02 from launching on the US market.

1. Canada Clears Alvotech Adalimumab Biosimilar for Launch

Health Canada approved Alvotech’s adalimumab biosimilar for launch on the Canadian market, where it will be marketed as Simlandi. The approval granted Alvotech permission to launch the product immediately. Humira generated over $700 million in 2020 for AbbVie. Simlandi is available as a 40-mg/0.4-mL and 80-mg/0.8-mL doses in prefilled syringes and self-injector pens. The news came shortly after Celltrion Healthcare received approval or its adalimumab biosimilar (Yuflyma) in January 2022.

News surrounding biosimilars referencing Humira (adalimumab) topped the list of biosimilar articles related to rheumatology in 2022, highlighting the excitement for these biosimilars to launch starting in early 2023. 

The Top 5 Rheumatology Articles of 2022

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, gives his thoughts on the necessity of clinical efficacy testing for biosimilar approvals, switching studies to establish interchangeability, and the promotion of biosimilars within company environmental and social impact reports.

Lately, there have been a number of efforts to try to remove clinical efficacy testing for biosimilars and to remove switching study requirements for establishing interchangeability. What is Biogen’s view on these efforts and do you think removing these requirements would create more confusion about biosimilar safety?

The intent of these discussions is to maybe open up the market. Some may see it as to lower the threshold. But we should recall that the body of evidence to get a regulatory approval is generally only the preclinical aspect. So, it's about the technical process, the manufacturing, etc. If we divide the clinical studies into 2, phase 1 and/or phase 3, you need to probably keep phase 1 for the right reasons, except in certain circumstances where you don't want to be putting an active drug into, say, an eyeball. 

If you did, under the scenario that you did eliminate a phase 3 study, because the body of the totality of evidence found—for example, in Europe, is 1 million patient-years of data—you would then say, "Does that prove anything? Is it necessary in terms of confirming comparability between the innovator and the biosimilar?" In that circumstance, you wouldn't do switching studies, and therefore, you wouldn't have an interchangeability discussion. 

But I think the discussion is, if the body of evidence is within the early preclinical stage, which is about comparability within certain tolerances and also includes a phase 1, you've probably covered most of the question marks around switching from one biologic to another biologic to another biologic, which, by the way, is what happens when you go from one innovative batch to another innovative batch to another innovative batch. They're all similar to the first reference batch, and I think that is where the body of evidence and real-world data starts to come to play and actually opens up the possibilities of this marketplace.

Earlier this year, The Center for Biosimilars

 wrote a piece on how companies are using their biosimilar development portfolios as part of their environmental and sustainability reports and social impact reports. Why is it important for companies to establish how their biosimilar portfolios impact the world?

So, commitment to ESG [environmental, social, and corporate governance] is a long-term journey for everybody. That's number 1. I think number 2 is, we have been reporting on that at Biogen for some time. And number 3, when we look to the future and what we can do, most importantly, what our customers are now asking us to provide evidence on, they're asking us to provide evidence of our ESG credentials within some of the contract structure of tenders and contracts. And I think that's good. That's a step forward. Again, that will move forward as we start to think about some of our COP [United Nations Climate Change Conference] commitments across the across the world.

Videos

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, shares his thoughts on whether clinical efficacy and switching studies to establish biosimilar safety are necessary, a hotly debated topic in the biosimilars industry.

Biogen's Ian Henshaw Weighs in on Clinical Efficacy, Switching Studies for Biosimilars

Both 2020 and 2021 were slow years for biosimilar approvals in the United States, but there were 7 total approved as of mid-December 2022. As more biosimilars come to market in the United States, there is interest in understanding how to implement biosimilars in practice and the cost savings that can be realized from greater use of biosimilars.

Here are the top 5 most popular biosimilars articles from 2022.

5. Patient Experiences, Oncologist Perceptions Differ for Trastuzumab Biosimilar Switch

Switching from a reference product to a biosimilar commonly happens for nonmedical reasons. Biosimilars are less expensive than the reference biologic and insurers or health care systems may lead the decision for this nonmedical switching.

However, a set of surveys revealed that patients and oncologists need improved communication regarding switching to trastuzumab biosimilars, and 41% of patients reported receiving no prior notification ahead of the switch. None of the oncologists surveyed reported that the decision to switch to a biosimilar was initiated by them.

4. High-Concentration Version of Adalimumab Biosimilar Will Be Available in 2023

While the FDA had approved multiple adalimumab biosimilars prior, this represented the first high-concentration citrate-free formulation of an adalimumab biosimilar approved by the FDA. Both the low- and high-concentration versions of Samsung Bioepis’ adalimumab biosimilar, Hadlima, will launch July 2023.

The citrate-free, high-concentration version reduces site injection pain. Currently, the high-concentration version of the reference product has the most market share.

3. Biosimilars Available for 3 Drugs Costing More Through Hospitals, Physicians

A report from AHIP analyzed the cost of 10 drugs and found those administered in a hospital or physician’s office can cost up to twice as much as the same drugs dispensed in specialty pharmacies.

Three of the drugs evaluated have multiple biosimilars available: Herceptin with 5 biosimilars available; Remicade with 4 biosimilars approved and 3 on the market; and Rituxan with 3 biosimilars available.

2. FDA Approves Third Bevacizumab Biosimilar

In April 2022, the FDA approved Alymsys, a bevacizumab biosimilar from Amneal Pharmaceuticals and mAbxience. It was the third biosimilar referencing Avastin to be approved in the United States. Alymsys was also the second biosimilar from Amneal approved in 2022.

 of 2022 was Releuko, a filgrastim biosimilar. The company also had a pegfilgrastim biosimilar, Fylnetra, that 

1. Dr Timothy Murphy Discusses Successfully Implementing Biosimilars Into Community Cancer Practice

Timothy Murphy, MD, medical oncologist/hematologist with Rocky Mountain Cancer Centers (RMCC) discussed how his practice is handling the growing number of biosimilars. Educating providers and the pharmacy team was crucial for the success RMCC had had.

“We had to convince our providers that switching the drugs that they have written for with a biosimilar was an OK thing to do, that these medications are just as efficacious as the name brand drugs that they may have actually written for it,” he said.

The American Journal of Managed Care, a sister site of The Center for Biosimilars, looked back at some of the most popular biosimilars content of 2022 to be published on AJMC.com.