Reference Product
Recently Published Documents





Ahmad Zainal Abidin ◽  
Centaine L. Snoswell ◽  
Leila Shafiee Hanjani ◽  
Gavin Callaghan ◽  
Michelle Edmonds

Nehad J. Ahmed

Aim: The aim of this study was to investigate physicians' opinions on the required information about biosimilars and the need for biosimilars related education. Methodology: The study included a survey that was prepared using a survey from a previous study and after face validation and content validation, it was prepared as an online form using the SurveyMonkey platform. Results: The majority of physicians stated that the most important information about biosimilars are studies that provide clinical immunogenicity data for the biosimilar and reference product (93.33%) in addition to studies that directly compare clinical efficacy and safety between reference products and biosimilars (88.89%). The majority of physicians stated that tracking safety events with biosimilars (94.45%) and access to information on studies comparing biosimilars with reference biologics (91.11%) are important issues related to biosimilars in professional environments. Conclusion: The present study highlights the needs of physicians for biosimilar education. More efforts are needed to increase the awareness regarding biosimilars by different formats in order to integrate biosimilars into clinical practice and to counsel patients about biosimilars.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 73-73
Amit Sanyal ◽  
Michelle Schmitt ◽  
Daniel Wellner

73 Background: Biosimilar drugs, defined as biologic products with no clinically significant differences in quality, efficacy and safety compared to approved reference products have gained increasing adoption based on studies projecting significant cost savings[1]. Real world evaluation of biosimilar related cost savings and adoption is however still limited. We prospectively evaluate cost savings generated by transitioning to biosimilar monoclonal antibodies in a community based oncology practice. Methods: In July 2020, a process for transitioning patients to biosimilar equivalents of Rituximab, Trastuzumab and Bevacizumab was implemented in a community based oncology practice. Provider adoption was facilitated by monthly oncology pharmacy governance meetings that allowed provider participation and feedback followed by defaulting the preferred biosimilar product in oncology chemotherapy software (Epic Beacon, Epic Systems, Verona, WI). The treatment templates allowed for care personalization by listing reference products that could be chosen if desired. Cost savings achieved by switching to biosimilars was calculated by subtracting the actual spending on the biosimilar product from projected acquisition cost of the branded reference product (Table). Biosimilar adoption, defined as amount of biosimilar drug used over total amount of the drug ordered was also calculated. Results: Between July 2020 and April 2021, transitioning to biosimilar products for Rituximab, Bevacizumab and Trastuzumab resulted in net savings of $268,194.64, $285,251.89 and $274,359.51 respectively. Actual spending on Rituximab biosimilar product was $726,476.10 against a projected spending of $994,670.74 on the branded reference product. Actual spending on Bevacizumab biosimilar product was $1,254,977.30 against a projected spending of $1,540,229.19 on the branded reference product. Actual spending on Trastuzumab biosimilar product was $1,218,641.60 against a projected spending of $1,493,001.11 on the branded product. Average biosimilar utilization between October 2020 and April 2020 has been 92%, 100% and 98% for Rituximab, Bevacizumab and Trastuzumab respectively. Conclusions: Significant cost-savings can result from widespread utilization of biosimilar drugs in community oncology practices. References: Mulcahy, A.W., J.P. Hlavka, and S.R. Case, Biosimilar Cost Savings in the United States: Initial Experience and Future Potential. Rand Health Q, 2018. 7(4): p. 3.[Table: see text]

Nutrients ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 3189
Mika Scheinin ◽  
Jouni Junnila ◽  
Giorgio Reiner ◽  
Anita MacDonald ◽  
Ania C. Muntau

Nitrogen balance is the difference between nitrogen excreted as urea and nitrogen ingested, mainly in proteins. Increased circulating concentrations of amino acids (AA) in the bloodstream are usually associated with proportional increases in the production and excretion of urea. Previously, we reported results from a randomized, controlled, single-dose, crossover trial in healthy adult volunteers (n = 30) (Trial Registration: ISRCTN11016729), in which a Test product (prolonged-release AA mixture formulated with Physiomimic Technology™ (PT™)) significantly slowed down the release and reduced the peak plasma concentrations of essential AAs compared with a free AA mixture (Reference product) while maintaining essential AA bioavailability. Here, we report an assessment of the nitrogen balance from the same study. The amount of nitrogen contained in plasma AAs, levels of blood urea nitrogen (BUN) (p < 0.0001) and changes in BUN (p < 0.0001) were smaller after the Test product compared with the Reference product. These findings suggest that the production of urea in proportion to systemic AA availability was significantly smaller after the administration of the Test product compared with the Reference product and that the test product conferred the increased utilization of AAs for protein synthesis and reduced their oxidation and conversion to urea. In the clinical setting, it is possible that the effects of PT™ observed on the disposition of free AAs in this study may translate to health benefits in terms of physiological body composition and growth if used for the treatment of subjects with phenylketonuria (PKU). Further investigation in patients with PKU is warranted.


Objective: Pharmacokinetic evaluation of Dimethyl Fumarate (DMF) in the Iranian population wasn’t studied. So, the aim of this research is the validation of the analytical method and evaluation of the pharmacokinetic properties and bioequivalence of the generic form of this drug versus the reference product. Methods: 2 single-dose, test, and reference DMF products were orally administered to 24 healthy volunteers. The washout period was 28 d between the treatments. Monomethyl fumarate as the metabolite of DMF was analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and the method was validated. Also, the pharmacokinetic parameters were calculated for bioequivalence evaluation. Results: The analytical method was validated and linear over the range of 31.25-4000 ng/ml (R2= 0.997). In addition, the method was precise and accurate in the low, medium, and high concentrations. The results indicated that the 2 products had similar pharmacokinetics. Further, the 90% CI of the mean ratios of the test versus the reference products of the log-transformed area under the concentration-time curve over 10 h (0.99 to 1.02) and peak concentration (0.98 to 1.03) were within the acceptable range of 0.8 to 1.25 and the generic product of DMF could be similar to that of the reference product. Conclusion: The applied analytical method is selective, accurate, precise, and repeatable for the analysis of monomethyl fumarate (MMF) in plasma. Also, the bioequivalence study showed no significant difference between the pharmacokinetic parameters of these 2 products. So, the DMF test product can be claimed to be bioequivalent with the reference product.

Gels ◽  
2021 ◽  
Vol 7 (3) ◽  
pp. 108
Tanikan Sangnim ◽  
Pornsak Sriamornsak ◽  
Inderbir Singh ◽  
Kampanart Huanbutta

Dysphagia refers to difficulty swallowing certain foods, liquids, or pills. It is common among the elderly with chronic diseases who need to take drugs for long periods. Therefore, dysphagia might reduce compliance with oral drug administration in the aging population. Many pharmaceutical companies search for new products to serve as swallowing aids. Existing products are expensive and do not suit all geriatric patients. Therefore, this study aimed to develop and investigate pill swallowing aid gels prepared from carboxymethyl cellulose and chitosan. We formulated gels by dissolving different concentrations of carboxymethyl cellulose and low or high molecular weight chitosan in solvents to find appropriate gel rheology properties. We then added several portions of glycerin as the glidant of the formulation. We found that the optimized gel formulation was 6.25% (w/w) chitosan with a molecular weight of 80–120 kDa dissolved in 1.2% acetic acid and 4% (w/w) glycerin. The developed pill swallowing gel’s rheology was pseudoplastic with a viscosity of 73.74 ± 3.20 Pa⸱s. The developed chitosan gel had enhanced flow ability; it allowed the pill to cross a 300 mm tube within 6 s, while the reference product took 3 s. Even though the reference product could carry the pill in the tube faster, the chitosan gel better covered the pill, making it more convenient to use. Finally, using a theophylline tablet as a model tablet dosage form, we assessed the gel’s effect on drug disintegration and dissolution. The chitosan gel delayed the tablet disintegration time by about 3–7 min and slightly affected the theophylline dissolution rate. Lastly, all gels were physically stable after a month of storage in the stress condition. These results show the feasibility of manufacturing a chitosan gel usable as a pill swallowing gel for patients with dysphagia.

2021 ◽  
pp. 107815522110316
Fatih Gürler ◽  
Demet Döndü Kasım ◽  
Bediz Kurt İnci ◽  
Osman Sütçüoğlu ◽  
Oktay Ünsal ◽  

Introduction To evaluate biosimilar understanding and preference trends of medical oncologists in Turkey. Methods A survey consisting of 24 multiple-choice questions with checkbox answers was conducted among medical oncologists. The questionnaire was divided into five parts to some intentions: demographic characteristics, general knowledge about biosimilars, knowledge about local approval and reimbursement issues, individual preference trends, and ranking the knowledge of their own. All answers were analyzed as whole cohort, specialists and fellows. Results Fellows (n = 47) consisted 42%, and academic clinicians (n = 37) consisted 35% of the participants. In the whole cohort, the overall rate of correct answers was 55.1% in the general knowledge about the biosimilars part, and 26.7% in the local approval and reimbursement issues part. At all, 57.7% of the participants declared that they object to switch from a reference product to a biosimilar product. The rate of those who defined themselves as extremely knowledgeable decreased from 8.1% to 2.7% in the whole cohort at the end of the survey. Conclusion The need for more accurate and clarified local regulations and education emerging in the biotechnology era must be met.

BioDrugs ◽  
2021 ◽  
Katariina M. Hutterer ◽  
Anna Ip ◽  
Scott Kuhns ◽  
Shawn Cao ◽  
Mats Wikström ◽  

Sign in / Sign up

Export Citation Format

Share Document