Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

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 found comparable efficacy, safety, immunogenicity, and pharmacokinetics (PK) in SB15 vs reference aflibercept (AFL; Eylea), both as a first-line therapy and after switching from AFL to SB15 in neovascular age-related macular degeneration (nAMD).

A phase 3, prospective, double-masked, randomized trial had to include treatment-naïve subfoveal choroidal neovascularization (CNV) with AMD occupying at least 50% of the total lesion, a total lesion area of 9 or more disc areas (DA; including blood, scars, and neovascularization).

The main study period followed patients for up to 32 weeks. Patients were randomized to receive either 2 mg intravitreal injections of SB15 or AFL every 4 weeks for the first 3 injections followed by dosing once every 8 weeks up to week 48. At week 32, patients on the originator were re-randomized to switch to SB15 or maintain prior treatment (AFL/SB15 group; AFL/AFL group).

Efficacy was determined using optical coherence tomography combined with Early Treatment Diabetic Retinopathy Study charts based on retinal images found by a central reading center. Overall quality of life was measured using the National Eye Institute 25 Item Visual Function Questionnaire. Secondary efficacy endpoints were found in the changes in baseline best-corrected visual acuity (BCVA) score, up to week 56 along with proportions of participants losing less than 15 letters or gaining 15 or more letters.

Results included 56 study centers across Europe, US, Russia, the Republic of Korea, and Japan with a total of 425 participants completing 56 weeks of data from June 2020 to February 2021. Demographics from baseline to week 32 included similar ages across each group, majority of the cohort being female, White, and from European regions.

The BCVA total letter scores were similar values before and after switching (SB15, n = 10.6; AFL, n = 1.19, AFL/SB15, n = 11.37; AFL/AFL, n = 11.12). There were no significant differences in central subfield thickness (CST) from baseline to week 32 (SB15, 95.61 µm; AFL, 121.96 µm; AFL/SB15, 126.24 µm; AFL/AFL, 119.81 µm) nor did the total retinal thickness (TRT) in the SB15 and AFL groups before the switch (140.06 mm

, respectively) or afterwards (AFL/SB15; 166.17 mm

Patients with nAMD had almost no changes in choroidal neovascularization (CNV) area before or after switching (SB15, 4.34%; AFL, 4.76%; AFL/SB15, 4.59%; AFL/AFL, 4.86%). The subtle data changes acknowledge the comparable efficacy between SB15 and AFL.

At week 32, about 97.6% of participants from baseline continued treatment after switching but 94.7% completed the entire 56-week trial.

Regarding BCVA, the treatment groups had similar least mean square (LSmean) results (SB15/SB15, 7.4 letters; AFL/AFL, 7 letters; AFL/SB15, 7.9 letters). No notable changes in CST during the study period were observed (SB15, 119.2 µm; AFL/AFL, 126.6 µm; AFL/SB15, 136.4 µm). There were no significant changes in TRT from baseline to week 56 (SB15/SB15, 132.4 µm; AFL/AFL,136.3µm; AFL/SB15, 151.1 µm). The changes in CNV size before and after the treatment switches were not significantly different (SB15/SB15, 1.26 mm

Most treatment-emergent adverse events (TEAEs) were mild or moderate, usually unrelated to the study drug or injection procedure, ensuring treatment safety. Each group had the presence of TEAEs in comparable amounts (SB15/SB15, 36.50%; AFL/SB15, 35.10%; AFL/AFL, 29.80%). The rates of non-ocular TEAEs were comparable between the groups (SB15/SB15, 25.10%; AFL/SB15, 22.50%; AFL/AFL, 23.10%). Ocular TEAEs by preferred term in the study eye had more patients experiencing cataracts and visual acuity reduction in the SB15 and AFL continuation groups while the AFL/SB15 group had higher percentages of posterior capsule opacification and xerophthalmia. 

The study showed comparable treatment-induced and treatment-boosted antidrug antibodies (ADAs) between all groups. Following week 32, 1% of the AFL/AFL group developed treatment-induced ADAs but the SB15/SB15 and AFL/SB15 did not.

Prior to week 32, serum concentrations were similar in PK between SB15 and AFL groups. After switching, all treatment groups were below the limit of quantification, measuring C

 predose at weeks 40 and 56 (BLQ; 5 ng/mL).

Limitations of the study are the small sample sizes of the AFL/SB15 and AFL/AFL treatment groups in comparison with the SB15/SB15 groups. The study should be reviewed cautiously at week 56 because it was not meant to assess equivalence between treatment groups.

The biosimilarity of SB15 maintained comparable efficacy, safety, immunogenicity, and PK to AFL throughout 56 weeks in patients with nAMD. Overall, the study supports switching patients from AFL to SB15 treatment.

Woo SJ, Sadda SR, Bradvica M, et al. Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial. 

. Published online December 29, 2023. doi:10.1136/bmjophth-2023-001561

Articles

A study found SB15, an aflibercept biosimilar, is just as effective as its reference drug Eylea, the current standard treatment for neovascular age-related macular degeneration (nAMD), a condition that causes vision loss.

SB15 Effective, Safe in Treating nAMD Before, After Switching

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 found significant increases in access to biologic disease-modifying antirheumatic drugs (bDMARDs) and janus kinase inhibitors (JAKis) in higher-priced innovative drugs instead of cheaper tumor necrosis factor inhibitors (TNFis) among patients with rheumatic musculoskeletal diseases (RMDs) over a 10-year time period.

A public payer database collected research on biological treatments and synthetic drugs during the biosimilar market competition period in RMDs from 2013 up until 2022. In total, 22,104 patients with RMDs were treated with either adalimumab (ADA), etanercept (ETN), infliximab (INF), certolizumab (CZP), golimumab (GOL), rituximab (RTX), tocilizumab (TCZ), secukinumab (SEC), ixekizumab (IXE), tofacitinib (TOF), baricitinib (BAR), and upadacitinib (UPA). The TCZ patient data includes intravenous (IV) and subcutaneous (SC) options.

Each drug was categorized based on the mechanism of action it had on either rheumatoid arthritis (RA), psoriatic arthritis (PsA), or axial spondylarthritis (axSpA) patients. Medications were deciphered as TNFi, interleukin (IL)-6 inhibitors, anti-CD20, IL-17 inhibitors, and JAKis. Subgroups were divided into less costly TNFi and other TNFi.

The results of patients with RMDs and treatment access in Poland increased notably from introduction, following the 10-year study period. Between 2013 and 2022, 16,979 more patients received treatment with bDMARDs or JAKis (RA, n = 8,239; PsA; 3,696; axSpA, n = 5,044). The overall percentage of patients with access to bDMARDS and JAKis increased from 0.8% to 3.2% for RA, 1.4% to 8.7% for PsA, and 0.8% to 3.5% for axSpA.

The peak value of cost treatment was reached in 2018 but decreased for the following 3 years. In 2018, approximately €31 million in cost savings were accumulated; however, it took from 2019 to 2021 for the same amount to accumulate again. The largest decrease in the average cost of therapy occurred in 2019, the same year as the first ADA biosimilars reimbursements. These calculations remained consistent throughout 2020, but increased in 2021 and 2022, when the number of patients treated with bDMARDs or JAKis increased overall. 

The 3 largest increases in drug utilization and distribution occurred in the ADA, TCZ, and SEC. Cheaper TNFis like ADA, ETN, and INF and their biosimilars had larger increases while CZP, GOL, IL-6 inhibitors, IL-17 inhibitors, and JAKis followed.

The most common agent for patients with RA was TCZ (n = 3,278), ADA (n = 1,398), and ETN (n = 1,913). Patients with PsA were mostly treated with ADA (n= 1,398), then SEC (n = 1,205). Similarly, axSpA found ADA (n = 2,413) was most dominant, followed by ETN (n = 1,219), and SEC (n = 1,058).

The impact of the COVID-19 pandemic on access to treatment hindered the availability of IV treatment therapies. Other SC or oral therapies did not experience changes in use over the pandemic, including TCZ SC. It is likely there was a temporary suspension of the administration of IV INF, RTX, and TCV for some patients during the global societal restriction. The general RMDs population chose SC affordable therapies as their preferred method of treatment.

Patients with PsA and axSpA mostly utilized ADA and ETN, while patients with RA mainly utilized TCZ. A Among the overall RMD population, the use of cheaper TNFis (ADA, ETN, INF) dropped from 87% in 2013 to 69% in 2016 to 46% in 2022 compared to other drugs. While physicians in Poland are responsible for providing therapy options for patients, the market share of the less costly agents remains high.

From 2019 to 2021, the biosimilar market had the greatest net benefit out of 10 years. On average, annual treatment therapy costs for patients with RMD declined by 60% over the 10 year span.

Limitations include the public payer data neglecting all cases using the described treatment methods and does not account for epidemiologic variation in the RMD population over time.

Innovative treatment developments should consider patients’ socioeconomic status, country regulations, cost reimbursements, and patient preferences for oral or SC formulas. Policy implementation is necessary for bDMARD users to incentivize them to reinvest in reimbursement options of less costly agents to take advantage of their access.

Stajszczyk M, Kwiatkowska B, Żuber ZM, Batko B. Access to biologics and JAK inhibitors for the treatment of rheumatic diseases in the biosimilars era in Poland: nation-level study. 

A 10-year analysis in Poland found that the introduction of biosimilar drugs significantly increased access to biologic therapies and Janus kinase (JAK) inhibitors for patients with rheumatic musculoskeletal diseases (RMDs), while also reducing treatment costs. 

Biosimilars Improve Access to Biologic Therapies, JAK Inhibitors for Patients With RMDs

The Top 5 Biosimilar Articles for the Week of January 22, 2024.

 uptake patterns within different health insurance plans found that low-flexibility plans, such as health maintenance organizations and exclusive provider organizations, were more likely to initiate biosimilar therapies than more flexible plans.

 (Rixathon and Truxima) and the reference drug (Rituxan) exhibited similar safety and efficacy outcomes in patients with immune thrombocytopenia (ITP), an autoimmune disease followed by a low platelet count, according to a recent analysis.

 Coherus Biosciences’ on-body injector version of Udenyca (pegfilgrastim-cbqv), making it the first biosimilar to reference Neulasta Onpro, the pegfilgrastim product that holds the majority of the pegfilgrastim market share.

 biosimilars concluded that these biosimilars “can be used as safely as their respective reference biologics.”

, the IQVIA Institute for Human Data Science predicted that losses for originator products will rise from $111 billion to $192 billion by the end of 2028, thanks to market introductions of 

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Here are the top 5 biosimilar articles for the week of January 22, 2024. 

The Top 5 Biosimilar Articles for the Week of January 22

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 of 3 pharmacokinetic (PK) studies found comparable results in the bioequivalence margins, safety, and immunogenicity between MB02, a bevacizumab biosimilar, and the EU- and US-sourced reference product (Avastin).

Bevacizumab is a biologic medicinal product inhibiting angiogenesis by binding to vascular endothelial growth factor (VEGFs) and preventing its interaction with VEGF receptors on the surface of endothelial cells. The drug typically

 colorectal, nonsquamous non-small cell lung cancer, glioblastoma, kidney, cervical, and renal cell carcinoma.

The phase 1 studies were single-dose, double-blind, three-arm, parallel group designs. MB02-A-02-17 and MB02-A-05-18 analyzed the use of the EU-approved and US-approved reference product compared with the biosimilar in healthy Caucasian males. The third study (MB02-A-04-18) examined Japanese male participants treated with MB02 or the EU-sourced originator, where the duration covered more than 3.5 times the terminal half-life of bevacizumab.

MB02-A-02-17 collected data from 2 sites in the United Kingdom (UK) from November 2018 to May 2019, MB02-A-05-18 pooled data from a single center in Germany from September 2019 to March 2020, and MB02-A-04-18 contained data from a single Japanese center from August to December 2019.

All patients were randomized to receive a 3 mg/kg single 90-minute intravenous dose of either MB02, the reference EU-bevacizumab, or US-bevacizumab. The study population only included men, revealing few differences between demographics. The age range of the UK and German participants was 18 to 55 years, and the range for the Japanese participants was 20 to 55 years.

Study periods were 100 days for the UK and German studies, while the Japanese study lasted 70 days. Covance Laboratories performed the analyses with a validated enzyme-linked immunosorbent assay on their serum drug concentrations for MB02 and reference bevacizumab.

The PK parameters were measured by treatment group and as overall populations. The area under the serum concentration subtracted by the time curve measured from time zero and extrapolated to infinity did not express notable differences among MB02 or either of the EU- and US–reference bevacizumab groups (30258.8 vs 26091.65 vs 26436.53, respectively). The area under the serum concentration minus the time curve measured from time zero to the time of last quantifiable concentration did not include differences between the MB02 and EU- or US-bevacizumab groups (28811.74 vs 26091.65 vs 26436.53, respectively).

Maximum observed serum concentrations did not have any major differences among the 3 studies analyzed (MB02, 82.49; EU -bevacizumab, 77.57; US-bevacizumab, 71.92). The time of maximum observed serum concentration were almost identical between groups (MB02, 3; EU- and US-bevacizumab, 4). All pairwise comparisons within the studies had remained within the predefined bioequivalence margins, including the terminal half-life, total body clearance, and the volume of distribution during the terminal elimination phase.

Overall, 186 participants (67.4%) reported 483 treatment-emergent adverse events (TEAEs). Two reference bevacizumab groups had a higher report (166 TEAEs in EU-bevacizumab; 169 TEAEs in US-bevacizumab) of TEAEs compared with the MB02 group (148 TEAEs). The US-bevacizumab group had more TEAEs than the EU-bevacizumab and the MB02 group (80.3% vs 63% vs 62%, respectively). Most TEAEs were of mild severity and were similar between the studies (MB02, 52%; EU-bevacizumab, 43%; US-bevacizumab, 63.2%). The most frequent TEAEs were headaches and nasopharyngitis.

The MesoScale Discovery assay was utilized to determine the serum concentrations of antidrug antibodies. The studies had similar treatment induced antidrug antibodies developed in a total of 41 participants (MB02, 14%; EU-bevacizumab, 16%; US-bevacizumab; 14.47%). Five participants had neutralizing antibodies after treatment (MB02, .02%; EU-bevacizumab, .01%; US-bevacizumab, .03%).

The study populations limited the findings because the researchers did not correct the results from Asian participants to reflect the previous descriptions for bevacizumab PK characteristics. Additionally, the studies had short study periods and differing selected sampling schedules.

The authors noted that this is the largest known analysis in the field of biosimilar monoclonal antibodies, providing further evidence on PK similarities through larger populations.

Miguel-Lillo B, Sánchez-Vidaurre S, Pérez Díaz L, Paravisini A. Pooled analysis of three pharmacokinetic studies comparing biosimilar MB02 and reference bevacizumab. 

. 2023;11(6):e01139. doi:10.1002/prp2.1139

A combined analysis of 3 studies found that the drug MB02 is comparable to reference bevacizumab (Avastin) in terms of its pharmacokinetics, safety, and immunogenicity.

Bevacizumab Biosimilar MB02 Demonstrates Bioequivalence in Key Safety Parameters With Avastin

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, found biosimilar use and market share higher in Medicare Advantage (MA) plans compared with traditional Medicare (TM) plans for most biosimilar products, except for bevacizumab.

Calculated cumulative data from May 2015 to September 2022 was used to evaluate biosimilar market shares for products with at least 1 biosimilar administration on or before September 30, 2019. A total of 20 biosimilar products were included, mainly used in Parts B and C, amongst 7 different product types.

Product types included infliximab, epoetin alfa, bevacizumab, pegfilgrastim, filgrastim, rituximab, and trastuzumab. Each product recorded a cumulative percentage market share from biosimilar introduction and throughout the 36 weeks following introduction. Market share was defined as the number of biosimilar administrations of the total administrations of biosimilars and their reference products.

 5 bevacizumab biosimilars, 4 infliximab biosmilars, 1 epoetin alfa biosimilar, 3 rituximab and filgrastim biosimilars each, 5 trastuzumab biosimilars, and 6 pegfilgrastim biosimilars. 

Vegzelma (bevacizumab-adcd), Mvasi (bevacizumab-awwb), Zirabev (bevacizumab-bvzr), Alymsys (bevacizumab-maly), and Avzivi (bevacizumab-tnjn) are the brand names for the bevavizumab biosimilars. Renflexis (infliximab-abda), Avsola (infliximab-axxq), Inflectra (infliximab-dyyb), and Ixifi (infliximab-qbtx) represent the approved infliximab biosimilars. Retacrit (epoetin alfa-epbx) is the only epoetin alfa biosimilar. Zarxio (filgrastim-sndz), Nivestym (filgrastim-aafi), and Releuko (filgrastim-ayow) are the filgrastim biosimilar products. Truxima (rituximab-abbs), Riabni (rituximab-arrx), and Ruxience (rituximab-pvvr) make up all the rituximab biosimilars. Kanjinti (trastuzumab-anns), Ogivri (trastuzumab-dkst), Ontruzant (trastuzumab-dttb), Herzuma (trastuzumab-pkrb), and Trazimera (trastuzumab-qyyp) all reference Herceptin (trastuzumab). Lastly, Nyvepria (pegfilgrastim-apgf), Ziextenzo (pegfilgrastim-bmez), Udenyca, (pegfilgrastim-cbqv), Stimufend (pegfilgrastim-fpgk), Fulphila - (pegfilgrastim-jmdb) and Fylnetra (pegfilgrastim-pbbk). In January, the on-body injector version of Udenyca was approved to compete against Neulasta Onpro (on-body injector reference pegfilgrastim).

Out of 6 of the 7 product types, results showed that MA plans had greater biosimilar uptake than TM plans. MA plans had 1.1 and 2.3 times greater uptake for trastuzumab and epoetin alfa biosimilars, respectively, compared with TM plans. All 7 products had a 1.3 (range, 0.7-2.3) median ratio for both MA and TM, with a median difference of 5.7% (range, –4.48% to 9.43%).

However, the products producing the least amount of biosimilar market share differed between MA and TM. For epoetin alfa biosimilars, MA had 5.7% times greater uptake than TM. Bevacizumab biosimilars had the lowest biosimilar market share for MA, with a –4.48% percentage point difference between plan types.

The indicator for bevacizumab was divided into ophthalmic vs oncologic usage. Although the reference product (Avastin) is only indicated for oncology use, it is often prescribed off-label for neovascular age-related macular degeneration. In the ophthalmic group, bevacizumab biosimilars had very low market share. However, market share was higher in TM plans than MA plans.

Data for epoetin alfa biosimilars, which originally had 2 times greater market share in MA plans than TM plans was stratified by end-stage kidney disease (ESKD) and non-ESKD utilization. Like other product types, epoetin alfa biosimilars had 1.5 to 1.7 times greater uptake in MA plans than TM plans. Combining uptake for ESKD and non-ESKD indications resulted in a higher relative weighting of MA biosimilar use.

Study limitations included the potential differences in population characteristics amongst MA and TM. The implementation of the Medicare inflationary rebate could also affect the biosimilar use and market share percentages of MA or TM.

The authors suggested that additional studies should incorporate all avenues of clinical indications. The authors concluded, “Thus, it is important to validate the increased biosimilar uptake observed in MA and investigate potential mechanisms through which managed care may encourage greater biosimilar use.”

Kozlowski S, Kwist A, McEvoy R, et al. Biosimilar uptake in medicare advantage vs traditional medicare. 

. 2023;4(12):e234335. doi:10.1001/jamahealthforum.2023.4335

Biosimilar uptake was greater in Medicare Advantage plans when compared with traditional Medicare plans. 

Greater Biosimilar Uptake Found in Medicare Advantage Than Traditional Medicare

The Top 5 Biosimilar Articles for the Week of January 15

Number 5: Sarafraz K. Niazi, PhD, previews the new year and his hopes for the 

 for biosimilar approvals using examples from history of other scientific concepts that took time to gain traction.

 has announced that it will remove AbbVie’s blockbuster immunosuppressive drug Humira from some of its preferred formulary drug lists in favor of more affordable biosimilar options for the drug. Starting April 1, 2024, Hyrimoz and an unbranded version of Humira manufactured by Sandoz will be covered across all CVS formularies, with branded and unbranded near copies of Humira manufactured by Biocon covered on some reimbursement lists.

Number 3: IQVIA’s report on the impact 

 has had on Europe’s health care space identified ongoing challenges with biosimilar access and generating savings, calling for more policies focusing on fostering a sustainable market for years to come.

Number 2: As Regeneron gears up for a legal battle with 

 for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson (J&J) for restricting biosimilar ustekinumab competition, and Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.

 (EMA) granted marketing authorization to Uzpurvo, the first biosimilar to reference Stelara (ustekinumab). The biosimilar is indicated for Crohn disease, psoriatic arthritis, and plaque psoriasis.

Here are the top 5 biosimilar articles for the week of January 15, 2024. 

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Two rituximab biosimilars (Rixathon and Truxima) and the reference drug (Rituxan) exhibited similar safety and efficacy outcomes in patients with immune thrombocytopenia (ITP), an autoimmune disease followed by a low platelet count, according to a recent analysis.

Between January 2018 and December 2019, an 

observational, multicenter, retrospective and prospective study

 was conducted among several medical centers in France. Study participants included adults with ITP who were administered at least 1 rituximab biosimilar infusion.

The main study objective was to evaluate the safety and efficacy of rituximab biosimilars in comparison with the reference product. Diagnosis was determined by international guidelines to determine the bleeding severity of the patients, graded from 1 to 19, where anything greater than 8 was labeled severe. The study examined data from 10 centers. The authors also noted that the real-life study scenario is comforting to patients and doctors who use or suggest this off-label drug when relying on accurate data research.

Outcomes were divided into complete response (CR), with a platelet count greater than 100 × 10

/L and partial response (PR), with a platelet count of 30 to 100 × 10

/L with at least a doubling of the pretreatment count. The final or overall response (OR) was either labeled as CR or PR. Patients labeled as non-responders required another treatment, including a new rituximab routine, despite the platelet count.

Treatment efficacy was calculated using the initial response rates between rituximab-naïve biosimilar patients and matched controls. The 3-month post-transfusion response was the main outcome determining efficacy. A total of 49 patients with ITP were administered Rixathon and 49 patients with ITP were treated with Truxima. There were 38 patients in the Rixathon group and 43 patients in the Truxima group. Patients had paracetamol, corticosteroids, and antihistaminic treatments administered as pre-infusion.

OR was achieved in 27/38 (71%) patients in the Rixathon group and 22/42 (51.2%) patients in the Truxima cohort. Following the first infusion, the median platelet count for the Rixathon cohort was 89 × 10

/L (range, 53.5-156.5) after the first 3 months. For the Truxima group, 82 × 10

/L (range, 50.3-197) was the median platelet count after 3 months. Ten patients experienced relapse after an average of 7.5 months.

The efficacy of the rituximab biosimilars in the matched analysis were observed. After 3-months following infusion, the overall response rate (ORR) was 76/142 (53.5%) for those receiving the originator and 47/74 (63.5%) for the patients receiving a biosimilar. The ORR at the 3-month mark was 26/34 (76.5%) for the Rixathon cohort and 35/68 (51.5%) for the reference product group. The reference product cohort had a remaining response of 24/57 (42.1%), whereas the Rixathon group had a remaining response of 18/28 (64.3%). The ORR for the Truxima group at 3 months was 21/40 (52.5%) vs 41/74 (55.4%)for the reference product group. At 12 months, the ORR for the Truxima group was 15/32 (46.8%) vs the 27/68 (39.7%) for the control group.

Patients receiving the reference product had similar responses compared with those who received the biosimilar.

Three patients receiving Truxima reported delayed effects and nonspecific adverse events after treatment. However, none were labeled severe nor needed hospitalization. 

The study was constrained by the absence of monitored B-cell depletion, which was not standard in France, thus, hindering comprehensive data. Additionally, the retrospective design and varied treatment timings among cohorts posed challenges to outcome completeness.

The study concluded, “The use of rituximab biosimilars for ITP treatment is a reliable option and offers hope for decreasing the cost of treatment for the challenged healthcare system.” 

Mageau A, Bonnotte B, Ebbo M, et al. Efficacy and safety of two rituximab biosimilars for treating immune thrombocytopenia: a reference-product matched study. 

. 2023;34(1):2200848. doi:10.1080/09537104.2023.2200848

A French study found that rituximab biosimilars, Rixathon and Truxima, were as effective and safe as the reference drug (Rituxan) in treating immune thrombocytopenia. 

Rituximab Biosimilars Effective in Treating Immune Thrombocytopenia

The Top 5 Biosimilar Articles for the Week of January 8, 2024. 

 found that combination therapies featuring trastuzumab biosimilars and other common cancer medicines were safe and effective in patients with breast cancer.

Number 4: Sarafraz K. Niazi, PhD, previews the new year and his hopes for the end of 

clinical efficacy testing for biosimilar approvals

 using examples from history of other scientific concepts that took time to gain traction.

 from Europe demonstrated that switching from Humira (reference adalimumab) to SB5 biosimilar was effective and safe for adults with inflammatory diseases, further supporting that SB5 can serve as a lower-cost alternative to the originator.

Number 2: The regulatory structure of biosimilar development can be safely streamlined and made 

, wrote authors from Sandoz, Fresenius Kabi, Boehringer Ingelheim, and Samsung Bioepis in an opinion article published in BioDrugs.

 has announced that it will remove AbbVie’s blockbuster immunosuppressive drug Humira (adalimumab) from some of its preferred formulary drug lists in favor of more affordable biosimilar options for the drug. Starting April 1, 2024, Hyrimoz and an unbranded version of Humira manufactured by Sandoz will be covered across all CVS formularies, with branded and unbranded near copies of Humira manufactured by Biocon covered on some reimbursement lists.

Here are the top 5 biosimilar articles for the week of January 8, 2024. 

The Top 5 Center for Biosimilars Articles for the Week of January 8

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 administered to German and Swiss pharmacists in prepandemic 2020 had patterns of repetition in postpandemic 2022 regarding knowledge of biosimilars, the technical definition, specific substitution laws by country, and attitudes when substituting with biosimilars.

Researchers used an online English-language survey questionnaire to collect data on pharmacists from Germany and Switzerland about how their knowledge and dispensing frequency of biologics and biosimilars changed from before and after the pandemic. The study was aiming to analyze and review pharmacists’ perceptions regarding dispensing biosimilar medications instead of the reference product.

The survey links were sent to Swiss pharmacists in February 2020 and June 2022, while German pharmacists received the links in May 2020 and June 2022. The 17 items of topic included characteristics of participants, definition of biosimilars, frequency of dispensing biologics and biosimilars, attitudes towards biosimilars, substitution and interchangeability of biosimilars, and information sources on biosimilars. In 2022, the survey added the topic regarding the impact COVID-19 had on their perceptions of biologics and biosimilars.

In total, 764 pharmacists participated in the surveys (n = 390 in 2020; n = 374 in 2022). The surveys included statistical data-based time frames to assess dispensing frequency, grouped into “≥2 times a week” and “≤1 time a week”. The researchers used the abbreviations “DE” to reference German pharmacists and “CH” to reference Swiss pharmacists. Knowledge was determined using questions where participants had to correctly identify definitions for biologics and biosimilars as well as their countries’ substitution laws.

There were no major differences in frequency of dispensing biologics among German or Swiss participants from 2020 to 2022 (≥ 2 times a week: DE, 67.9% vs 53.3% and CH, 54.8% vs 56.4%; ≤ once a week: DE, 32.1% vs 46.7% and CH, 56.4% vs 43.6%, respectively). However, Swiss pharmacists increased their dispensing frequency of biosimilars from 2020 to 2022 to more than twice a week (9.7% to 23.8%; 

Both German and Swiss pharmacists did not have significant differences in knowledge of the term “biosimilars” in either year. In 2020, 41.7% of German pharmacists and 50% of Swiss pharmacists accurately defined the term biosimilars on the survey. All participants had at least heard of the term biosimilar. However, the most common misconception was a biosimilar labeled as a generic biologic (DE: n = 46 in 2020; n = 34 in 2022 vs CH: n = 28 in 2020; n = 59 in 2022).

Attitudes towards biosimilars, including familiarity of the term biosimilar, feeling sufficiently informed about biosimilars and informed on administering them, along with being confident in handling patient queries about biologic therapies, were unchanged in German and Swiss participants. However, Swiss pharmacists were more confident with handling patient questions about biosimilars than German participants in 2022. Swiss pharmacists also had higher confidence in biosimilar substitutions.

Knowledge on substitution laws and sources of information was unclear in both groups. More Swiss pharmacists were unaware of substitutions being permitted (2020: 37.1% vs 7.1%, respectively; 

< .005), whereas more German pharmacists thought substitutions were allowed for insulin products only (2020: 7.1% vs 1.6%, respectively; 

Regarding the impact of the COVID-19 pandemic, data showed most pharmacists indicated similar interest in biologics and biosimilars (DE: 60% vs CH: 55.5%), a similar working style (DE: 56% vs CH: 65.4%), and a similar confidence in counseling on biologics and biosimilars (DE: 61.3% vs CH: 57.4%). However, their knowledge as well as the feeling of readiness to assume more responsibility of biologicals and biosimilars in the future remained unchanged from before and after the pandemic.

The study was limited by the survey being available only in German and English in Switzerland, despite the country having 4 national languages. The sample size (390 in 2020, 374 in 2022) hindered generalizations. Introduced solutions like financial incentives may have biased results towards more interested and knowledgeable participants, potentially overstating pharmacists' knowledge compared to broader populations in Switzerland and Germany.

The researchers noted that the lack of knowledge and confidence is an issue that must be addressed when it comes to substitutions of drug originators.

Messner K, Eickhoff C, Schulz M, Allemann SS, Arnet I. Knowledge and attitudes of German and Swiss community pharmacists towards biologicals and biosimilars - a prospective survey before and after the COVID-19 pandemic. 

. 2023;23(1):1432. doi:10.1186/s12913-023-10475-x

A recent study found that the COVID-19 pandemic had little impact on the knowledge and attitudes of German and Swiss pharmacists regarding biologics and biosimilars between 2020 and 2022.

Examining Attitudes in German, Swiss Pharmacists on Biosimilar Dispensing Pre- and Post Pandemic

The Top 5 CFB Articles for the Week of January 1

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 included the changing market dynamics in the adalimumab space, including new launches and interchangeability labels, as well as the addition of Stelara and Enbrel to the list of originators up for Medicare price negotiation.

 include the US market launch of Fylnetra, the sixth pegfilgrastim biosimilar on the market, the FDA approval for an autoinjector pegfilgrastim biosimilar, and more.

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 concerned clinical results, approvals, and launches for ranibizumab and aflibercept biosimilars.

top 5 most-read regulatory stories of 2023

 covered the FDA approvals for the first ustekinumab biosimilar and the first subcutaneous infliximab product, as well as other regulatory updates.

regulatory structure of biosimilar development

 can be safely streamlined and made more efficient and less costly, wrote authors from Sandoz, Fresenius Kabi, Boehringer Ingelheim, and Samsung Bioepis in an opinion article published in BioDrugs.

Here are the top 5 biosimilar articles for the week of January 1, 2024. 