Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

The Top 5 Biosimilar Articles for the Week of March 11, 2024. 

 analyzing 3 years of treatment patterns for patients with Crohn disease on biologics found that while more patients received infliximab, adalimumab, and vedolizumab initially, ustekinumab showed the highest persistence and lowest dose escalation rate, indicating potentially better clinical response compared to other biologics.

provided updates on how provider acceptance growth, evolving payer dynamics, and the growing pipeline for biosimilars will shape the biosimilar landscape over the next 5 years.

 (Tyenne; tocilizumab-aazg), making it the second tocilizumab biosimilar overall and first tocilizumab biosimilar to be approved with both intravenous and subcutaneous administration options.

Sarfaraz K. Niazi, PhD, takes a look at the 

European Medicines Agency's (EMA) announcement

 that it will investigate whether comparative efficacy tests should be needed for a biosimilar to receive regulatory approval.

 (denosumab-bddz; GP2411), the first biosimilar to reference Xgeva/Prolia (denosumab) in the US.1 The drugs will be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.

To read all of these articles and more, visit 

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Here are the top 5 biosimilar articles for the week of March 11, 2024. 

The Top 5 Biosimilar Articles for the Week of March 11

Patient treated with chemotherapy | Image Credit: NDABCREATIVITY - stock.adobe.com

A combination of trastuzumab biosimilar HLX02, pertuzumab, and chemotherapy exhibited efficacy and favorable safety as second and beyond line therapy in patients with HER2-positive metastatic breast cancer.

From March 2020 to December 2021, a Beijing Cancer Hospital held a 

prospective, single-arm, single-center, phase 2 clinical trial.

 Eligible participants included patients diagnosed with metastatic breast cancer who were previously treated with trastuzumab alone but experienced disease progression during or after therapy.

Based on the physician, patients were assigned trastuzumab (HLX02), pertuzumab and chemotherapy at baseline. Trastuzumab (HLX02) was administered intravenously as an 8 mg/kg loading dose followed by 6 mg/kg maintenance doses every 3 weeks. Pertuzumab was administered intravenously as an 840 mg loading dose followed by 420 mg maintenance doses every 3 weeks.

Every 6 weeks, tumor assessment was computed with a tomography scan of the chest and if the disease progressed after 6 months, the investigator made the decision on whether to continue chemotherapy or not. Trastuzumab and pertuzumab continued to be administered until disease progressed or toxicity became intolerable to patients.

Study results found treatment was well tolerated among participants. A total of 45 patients were included in the data with a median age of 56 years. Of the total number of patients, 12 (26.7%) were treated in second line, while 33 (73.3%) were treated in third line and later settings.

The primary endpoint of the study was the progression free survival (PFS), which was calculated from the time of first administration to the time of disease progression or death. Follow-up consisted of an average of 24.4 months, with 35 of the 45 patients enduring PFS events for about 7.6 months. There were no major differences observed in the subgroup analysis for PFS.

Overall survival, a secondary endpoint of the study calculating the time of the first administration to the time of death due to any cause, was unable to be reached due to the short follow-up period.

Another secondary endpoint of the study, objective response rate (ORR), was defined as the proportion of patients with measurable disease whose best overall response was evaluated as either complete remission (CR) or partial remission (PR). At the end of the study, 14 (31.1%) patients achieved PR, 27 (60%) had stable disease, and 4 (8.9%) had progressive disease. None of the patients had a CR.

Lastly, the disease control rate (DCR) was a secondary endpoint defined as the proportion of patients who achieved CR, PR, and stable disease (SD). Patients achieved a 31.1% ORR with a 91.1% DCR.

The safety profile of the treatments found most toxicities were grade 1 or 2 and manageable. The most common adverse events were neutropenia (n = 20 patients; 44%), anemia (n = 9; 20%), diarrhea (n = 9; 20%), and alanine aminotransferase/aspartate aminotransferase elevation (n = 8; 17.8%).

Adverse events graded a 3 or higher, mainly neutropenia patients (n = 3; 6.7%), were ruled to mainly be associated with chemotherapy instead of trastuzumab or pertuzumab. Overall, the study regimen did not exhibit any unexpected toxicities.

The study's main limitation was the single arm, single center study design. Additionally, the follow-up period was not long enough to allow for an overall survival analysis.

Authors concluded that their findings provide new evidence for treatment of dual-antibody therapy in late-line settings of patients with HER2-positive metastatic breast cancer.

Zhang R, Liu X, Song G, Zhang Y, Li H. Trastuzumab biosimilar (HLX02), pertuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer after progression of trastuzumab: A prospective, phase II study. 

. Published online December 20, 2023. doi:10.4143/crt.2023.1151

Articles

A study found combining trastuzumab biosimilar HLX02, pertuzumab, and chemotherapy was effective and safe for patients with HER2-positive metastatic breast cancer who progressed after prior trastuzumab therapy.

HLX02, Pertuzumab, Chemotherapy Combination Effective, Safe in Advanced HER2-Positive Breast Cancer

Biosimilars Versus Bad Patents: Accessibility, Key Court Cases With Ha Kung Wong, J.D.

Ha Kung Wong, JD, an intellectual property attorney specializing in intellectual property law partnered with 

, discusses the patent system and biosimilar accessibility in an interview with The Center for Biosimilars

. He acknowledges concerns regarding "bad patents" that could limit access to biosimilars but expresses confidence that the FDA and 

 [United States Patent and Trademark Office] will refine the system to only grant good patents.

Wong highlights specific court cases involving biosimilars, including 

. He advises stakeholders to follow these cases as they may have a significant impact on the biosimilar market. Despite the challenges of bad patents, Wong assures us that biosimilars are continuing to enter the market and driving down health care costs.

How does the patent system impact biosimilar accessibility and how can it be improved to better balance investor interests and the need for more affordable health care options?

By and large, the patent system is really no different with respect to biosimilar accessibility, as it is to small molecule accessibility or any other areas of life sciences.

As outlined in the Constitution, good patents help protect innovation, which in turn provides incentive for development of new life saving treatments, as well as disclosure of information to promote continued development of those treatments. The problem we have is that not all patents are good, right? There are bad patents and they can be impactful in terms of limiting health care options.

The FDA and the USPTO [United States Patent and Trademark Office] have been collaborating to provide a more robust patent system for pharmaceutical patents and more robust in terms of making sure good patents come out and not bad patents.

For instance, they propose more training and time for patent examiner's during prosecution, better examination means better patents, and they have encouraged increased disclosure of regulatory materials during prosecution.

This proposal could help to avoid patents being issued that should not be either based on not properly meeting the patentability requirements or by inappropriately overlapping with earlier issued patents, which could in turn lower the number of bad patents that biosimilars would have to contend with.

That being said, the patent system as is hasn't necessarily negatively impacted biosimilar accessibility. Biosimilars are getting to the market and are bringing prices down and providing more affordable health care, even when they don't necessarily capture large market shares.

According to the quarter for 2023 report by 

, the average sales price declined on average of 41% 3 years post-biosimilar launch and over 50% in the oncology space. There's a lot of benefit here from biosimilar launches and patents aren't necessarily stopping that from happening but we should be vigilant about bad patents. We don't want those to be allowed.

We’re starting to see some of the settlements for patent cases involving ustekinumab biosimilars as well as new cases regarding aflibercept biosimilars. What other biosimilar court cases should stakeholders be watching?

Well, there are a number of them and keep in mind that a lot of these biosimilars cases are fact specific so they won't necessarily result in something that will have wide ranging impact on the industry. But I do think there are a couple that we should keep an eye on.

First of all, Eylea has 5 pending lawsuits, a number of pending 

aBLAs [abbreviated Biologics License Applications

]. This is definitely going to be a drug to watch in terms of decisions and market impact.

Solaris, they had a first litigation related to the proposed Solaris biosimilar, SB12, which was just filed on January 3 of this year by 

 and again Samsung Bioepis. Samsung Bioepis provided its 180 day notice of commercial marketing over 6 months ago in July of 2023, which means it could launch at risk at any point after receiving FDA approval. It was a pending aBLA that was accepted by the FDA by July of 2023 so it's possible that launch could be soon if Alexion doesn't request supplementary injunction.

There's a lot of things here, a lot of moving parts here that we want to keep an eye on to see how that impacts the process when which a biosimilar might go through if they want to be aggressive and launch at risk. There's Tysabri, which has an ongoing litigation related to that 

 product, Tysabri, and there's a biosimilar 

, which was FDA approved in August [2023].

The preliminary junction was denied in June, Sandoz has expressed a plan to launch at risk in the first half of 2024. This would be the first biosimilar launch for Tysabri which was approved almost 20 years ago so certainly something to keep an eye on there as well.

Intellectual property attorney, Ha Kung Wong, JD, discusses concerns about "bad patents" hindering biosimilar access, but assures that the FDA and United States Patent and Trademark Office are working to improve the system.

Biosimilars vs Bad Patents: Accessibility, Key Court Cases With Ha Kung Wong

The Top 5 Biosimilar Articles for the Week of March 4

Congress of European Crohn’s and Colitis Organisation (ECCO)

, Celltrion and Samsung Bioepis presented new finding from their respective biosimilar analyses, demonstrating positive safety and efficacy measures for the biosimilars as treatments for Crohn disease (CD) and ulcerative colitis (UC).

 announcement that it will investigate whether comparative efficacy tests should be needed for a biosimilar to receive regulatory approval.

 Samsung Bioepis provided multiple updates on its biosimilar projects, including a 

 for its aflibercept biosimilar candidate as well as regulatory news in the European Union and Republic of Korea.

 After receiving 3 complete response letters, Alvotech has officially received 

US approval for its adalimumab biosimilar

 (AVT02; Simlandi), making it the first approval for the company, the 10th biosimilar to reference Humira, and the third interchangeable adalimumab biosimilar.

 primarily serve to uphold inflated list prices, typically prompted by loss of exclusivity, aiming to safeguard market share and counter biosimilar competition, although forthcoming legislative changes targeting high drug costs could lessen their significance moving forward.

Here are the top 5 biosimilar articles for the week of March 4, 2024.


Elder Asian woman with eye care treatment | Image Credit: Chinnapong - stock.adobe.com

Patients with neovascular age-related macular degeneration (nAMD) demonstrated comparable efficacy, safety, immunogenicity, and pharmacokinetics (PK) between reference aflibercept (Eylea) and QL1207, an aflibercept biosimilar.

 was conducted across 35 centers in China. Patients were screened from August 2019 to January 2022, and randomized to receive either 2 mg reference aflibercept or QL1207 intravitreally every 4 weeks for the first 3 months followed by 2 mg every 8 weeks until week 48. The phase 3 trial included participants 50 years or older who were blind to allocation along with assessors.

Out of 533 patients screened, a total of 366 were enrolled and assigned (reference group, n = 181; QL1207 group, n = 185). All 366 patients with nAMD were included in the full analysis set (FAS), while the per-protocol set (PPS) had 319 patients (aflibercept, n = 159; QL1207, n = 160). The FAS included patients who received at least 1 dose of the study drug and 1 efficacy assessment, and the PPS included patients in the FAS without any major protocol violations. The final analysis contained data on 321 patients, with 155 receiving reference aflibercept and 166 in the QL1207 group.

Results found the reference aflibercept group had an average (SD) age of 67.1 (8) years while QL1207 had an average of 67.4 (8.9) years. The average best-corrected visual acuity (BCVA) was 56.1 (11.7) letters vs 56.3 (11.8) letters, with 80% and 80.7% patients having a score of 45 letters or more. The mean central retinal thickness area was 428.2 (178.1) mm vs 463.5 (193.3) mm while average choroidal neovascularization (CNV) leakage areas were 3.99 (4.14) vs 3.99 (4.13) mm

On average, the BCVA changes in the FAS from baseline at week 12 were 11 (9.2) letters in the reference aflibercept group and 10.2 (8.8) letters in the QL1207 group. The least-squares mean (LSM) changes in BCVA were 10.4 letters vs 11.5 letters from baseline to week 12 with a difference of –1.1 letters. No significant differences were found among the primary endpoints in either group. Patients with a BCVA score greater than or equal to 45 letters had a –1 LSM difference while patients with less than 45 letters had a difference of –1.6 LSM at baseline. At week 12, the LSM remained within the equivalence margin.

From baseline to week 52, LSM changes were –183 mm vs –208.4 mm, with a 25.4 mm difference in LSM. At week 52, LSM changes in CNV leakage area were –2.72 vs –2.61 LSM with a corresponding difference of –0.11 mm

. Similarities at other timepoints were similar in the 2 groups as well.

Safety among the reference aflibercept and QL1207 groups had comparable incidences of treatment-emergent adverse events (TEAE; 71.8% vs 71.4%, respectively). Similar ocular (29.8% vs 28.1%), fellow eyes (13.8% vs 19.5%), and non-ocular TEAEs (56.9% vs 60%) were reported in the reference aflibercept and QL1207 groups, respectively. Intraocular pressure increased (13.3% vs 11.9%), conjunctival hemorrhage (6.1% vs 5.9%), eye pain (1.7% vs 2.7%), ocular hypertension (1.1% vs 2.2%), cataract (1.7% vs. 1.6%), and conjunctivitis (1.7% vs. 1.6%) were the most common TEAEs among the aflibercept and QL1207 groups, respectively. Neither group had TEAEs leading to death, but 4 patients in the reference aflibercept group and 2 patients in the QL1207 group discontinued treatment due to related TEAEs.

The immunogenicity and PK analysis included 365 patients with similar incidences of positive antidrug antibodies (ADAs) between reference aflibercept and QL1207 (7.7% vs 7.1%). Both groups had comparable plasma drug concentrations and PK parameters as well as similar vascular endothelial growth factor levels as well.

The study was limited to only Chinese patients which arises caution when considering these results for other ethnicities. The optical coherence tomography angiography was not implemented for the CNV assessment due to its lack of validation during study design in the clinical trial setting.

Authors concluded with their supported evidence of QL1207 as an alternative option to the originator when treating patients with nAMD in China.

Li B, Fan K, Zhang T, et al. Efficacy and safety of biosimilar QL1207 vs. the reference aflibercept for patients with neovascular age-related macular degeneration: A randomized phase 3 trial. 

2024;(13):353-366. doi:10.1007/s40123-023-00836-4

A Chinese phase 3 trial found biosimilar QL1207 to be as effective and safe as reference aflibercept (Eylea) for the treatment of neovascular age-related macular degeneration (nAMD).

QL1207 Biosimilar Shows Equivalent Efficacy, Safety to Aflibercept in Treating nAMD

The Top 5 Biosimilar Articles for the Week of February 26

The Revolution that Died on its Way to Dinner Table,

” reported in the New York Times on February 9, summed up the history of the gleaming vision of a world just beyond the present: a world in which a high-tech factory housing bioreactors will produce formed steaks, millions of pounds a day to feed the world at an affordable cost—

, Celltrion and Samsung Bioepis presented new finding from their respective biosimilar analyses, demonstrating 

Crohn disease (CD) and ulcerative colitis (UC)

 (VA) has chosen to replace Humira (adalimumab) with Organon’s biosimilar version on its national formulary; Biocon Biologics and Sandoz announce a new partnership in Australia for 2 biosimilars; Alvotech settles with Johnson & Johnson over its biosimilar to Stelara (ustekinumab) for the European and Canadian markets.

After receiving several complete response letters (CRLs), Alvotech has officially received 

FDA approval for its adalimumab biosimilar

 (AVT02; Simlandi), making it the first US approval for the company and tenth biosimilar referencing Humira (adalimumab). The product was also approved as an interchangeable biosimilar.

Here are the top 5 articles for the week of February 26, 2024.

Ha Kung Wong, JD 2

, brings a wealth of experience to the field of intellectual property law, specializing in patent and trade secret litigation. Beyond courtroom battles, his expertise extends to negotiating complex agreements for mergers, acquisitions, and collaborations across diverse industries, including pharmaceuticals, biologics, and cutting-edge fields like digital health and artificial intelligence. Wong's client roster boasts renowned names like Alkermes, Allergan, and the Bill & Melinda Gates Foundation.

 delved into Wong's insights in an interview on proposed patent law changes poised to significantly impact the biosimilars sector. These changes encompass limitations on asserted patents, the potential elimination of interchangeability requirements, and increased scrutiny of pharmacy benefit managers (PBMs).

Do you foresee any potential shifts or reforms in patent law that could positively or negatively impact the biosimilars sector in the near future?

Predicting whether there will be statutory shifts or reform in patent law is like trying to predict what will happen in the next 

 movie—you have no idea what specifically is going to happen but it's probably going to have some explosions that ultimately, will not be applicable to the real world. That being said, there are a few things I think that we might want to keep an eye on. I say "very few" only because we've seen a lot of things introduced and not a lot of follow through. There's a lot of good intentions out there, but there's not a lot of follow through. That being said, here it is.

First of all, Senators [Peter] Welch [D, Vermont], [Mike] Braun [R, Indiana], and [Amy] Klobuchar [D, Minnesota] introduced legislation in the Senate, and Representative [Jodey] Arrington [R, Texas] in the House on January 2024 that would limit the number of patents that could be asserted in a patent litigation. If this were to proceed, this may or may not have a practical effect because we've seen that most Bundled Payments for Care Improvement 

lawsuits that have been asserted are asserted on 10 or less patents. So, having an artificial limit may not make it any better. But it might. Who knows? It is certainly something to keep an eye on.

The Biosimilar Red Tape Elimination Act was introduced in July 2023 by Senators [Mike] Lee [R, Utah], [Ben Ray] Lujân [D, New Mexico], Braun, and [J.D.] Vance [R, Ohio]. That bill would eliminate the 2 separate designations of biosimilars and interchangables, which we know, exist in the US and we are the only country that does that. Every other country in the world only has 1 level of biosimilarity. It's possible if the interchangability requirement was removed, there could be greater uptake of biosimilars due to the possibility of automatic substitution at the pharmacy level, like we see with generic drugs. There may be increased confidence in biosimilars because they would be seen as perhaps closer to the reference product.

The problem is that when people hear there's a "biosimilar" but there's a higher level called "interchangable", their automatic reaction is, "Well that means biosimilars are garbage, why would I want that? I want an interchangeable. Oh, there's no interchangable? Then I don't want that product."

I think it will help with consumer confidence, patient confidence, and will help with health care provider confidence because a lot of doctors just don't know the difference. 

In June 2023, Senators [Thom] Tillis [R, North Carolina] and [Chris] Coons [D, Delaware] reintroduced the Patent Eligibility and Restoration Act of 2023 to reform patentability requirements under Section 101. There, the bill seeks to clarify which inventions are eligible for patenting in the US. If that bill were to be passed, it would overturn Supreme Court decisions in Mayo, Alice, and Myriad, which we've all been talking about for 10 years. It would be really interesting to see how that would impact the pharmaceutical and biologics industry in particular.

Finally, there's been this increased congressional scrutiny of pharmacy benefit managers or PBMs. Congress has launched various investigations into PBM practices and while this isn't directly related to patent law reform, it could have a significant impact on biosimilar uptake given the preferential formulary coverage of biosimilars and how that plays a big role in whether biosimilars are used and whether cost savings are realized or not.

I've been on record saying this for a long time now. PBMs are middlemen that don't need to really be there, but at the end of the day, they end up increasing the cost for patients and it would be interesting to see if all this congressional scrutiny will lead to better cost savings for patients.

Ha Kung Wong, JD, examines proposed patent law changes that could significantly impact the biosimilars sector, including limitations on asserted patents, elimination of interchangeability requirements, and heightened oversight of pharmacy benefit managers.



Patent Shift Predictions, Legal Landscapes of Biosimilars With Ha Kung Wong

The Top 5 Biosimilar Articles for the Week of February 19, 2024.

 In its market sustainability for infused 

, IQVIA echoed the need to address issues regarding misaligned incentives regarding rebates, slow or limited uptake, and concerns about market viability, which will be crucial for ensuring the long-term sustainability of biosimilars and maximizing their benefits for the health care system.

 After a patient with multiple sclerosis (MS) was forced to pay exorbitant out-of-pocket costs for a brand name medication when she could’ve gotten a generic for way less, the patient filed a class action complaint against her employer, Johnson & Johnson (J&J), for violating the 

 that 3 of its oncology biosimilar products have won tender contracts in France and Italy, and an experimental oral delivery device utilizing an ustekinumab biosimilar was successful in a phase 1 study.

efficacy, safety, pharmacokinetics, and immunogenicity

 were found when comparing Stelara, originator ustekinumab, and CT-P43, an ustekinumab biosimilar candidate, in patients with moderate to severe plaque psoriasis.

 assessing several disease states found no significant differences in serious adverse events, deaths, or treatment discontinuations between patients who switched from reference products to biosimilars and those who did not.

Here are the top 5 biosimilar articles for the week of February 19, 2024.

The Top 5 Biosimilar Articles for the Week of February 19

Doctor holds stethoscope surrounding rituximab text | Image Credit: MQ-Illustrations - stock.adobe.com

A phase 3, randomized, double-blind study

 conducted in China found bioequivalence between reference rituximab (Rituxna) and HanliKang (HLX01), a rituximab biosimilar, in the overall survival (OS) and progression-free survival (PFS) in patients with diffuse large B-cell lymphoma (DLBCL).

Rituximab is a monoclonal antibody used to treat DLBCL as well as other aggressive cancers. HanliKang (HLX01) was developed in line with the China National Medical Products Administration (NMPA) and the World Health Organization. On February 22, 2019, China NMPA approved HLX01 as the first biosimilar in their country.

China’s standard care in the first line setting for patients with DLBCL is the combination of rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). The researchers randomized patients to receive either R-CHOP intravenously or HLX01 combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (H-CHOP) as doses of 375 mg/m

Data from 27 hospitals across China was used to enroll 316 patients in the study, with the researchers using April 28, 2022, as a cut-off date (R-CHOP: n = 159; H-CHOP: n = 157). The 6 planned treatment cycles were completed by 91.8% of the R-CHOP while 87.3% patients made up the H-CHOP group. The median age of patients was 56.1 years old with the median duration of follow-up as 65.1 months. OS and PFS values were recorded at the 1-year, 3-year, and 5-year marks.

The International Prognostic Index (IPI) had 96.5% of patients in IPI 1 and 2, 47.2% had clinical stage III/IV disease, and 17.7% had bone marrow involvement. The study found no significant differences in efficacy or OS between either treatment groups. The 5-year OS rates were 75.4% and 81%, for R-CHOP and H-CHOP, respectively. For patients completing all 6 cycles, the 5-year OS rates were 77.6% and 83.3%, respectively. A similar number of patients died in both groups (R-CHOP, n = 41; H-CHOP, n = 31).

There were no statistically significant differences of PFS between the R-CHOP and H-CHOP treatment groups 5 years after completing all 6 cycles (PFS, 75.6% vs 79.6%).

For patients with low-risk DLBCL (IPI score 1 or 2), both R-CHOP and H-CHOP had similar 5-year OS rates (IPI 1: 80.2% vs 86.8%; IPI 2:68% vs 76.2%) and PFS rates (IPI 1: 75.3% vs 84.1%; IPI 2:68.2% vs 72%).

Patients with an IPI score of 1 had better outcomes than those with a score of 2 (OS: 83.1% vs 72.3%; PFS: 79.3% vs 70.2%). No significant differences were observed in OS or PFS between clinical stages I/II and III/IV (OS: 79.4% vs 76%; PFS: 79% vs 70.4%).

Limitations of the study included the likeliness of nonresponse bias with telephone follow-up and the absence of visual cues that compromise the data representation.

Study results were comparable with previous long-term follow-up studies administering rituximab in combination with chemotherapy in patients with DLBCL. Authors concluded, “HLX01 is an appropriate substitute for rituximab that can provide comparable efficacy in patients with low or low-intermediate IPI risk DLBCL.”

Qin Y, Song Y, Wang D, et al. Long-term outcomes with HLX01 (HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 study. 

. 2024;24(1):124. doi:10.1186/s12885-024-11876-9

A large Chinese study found that HanliKang (HLX01), a biosimilar rituximab, had similar overall survival and progression-free survival rates to the reference product (Rituxan) in patients with diffuse large B-cell lymphoma (DLBCL).

Biosimilar HLX01 Demonstrates Bioequivalence With Rituxan in DLBCL

The Top 5 Biosimilar Articles for the Week of February 12

 is just as effective as the originator drug (Enbrel) in treating Australian patients with rheumatoid arthritis (RA), leading to significant cost savings.

 showcased the success of biosimilars while also emphasizing the impact of inflation on different drug classes, particularly in oncology and immunology.

Since January 31, 2023, the United States has seen a boom in the adalimumab market. With 

 launching throughout the year, the US rheumatology, immunology, dermatology, and gastroenterology treatment spaces have a wealth of newer and cheaper alternatives to Humira (reference adalimumab).

In his latest column, Sarfaraz K. Niazi, PhD, highlights challenges in biosimilar development, emphasizing the 

 (USP) and advocating for collaboration and standardized guidelines to expedite cost-effective development without compromising safety or efficacy.

Here are the top 5 biosimilar articles for the week of February 12, 2024. 