An update on the animal studies conducted for biosimilar approvals - Regulatory requirement vs actual scenario.

Nonclinical animal studies are considered as an integral part of biosimilar development program to demonstrate similarity and safety. We have compiled, reviewed and summarized animal studies conducted for European Medicines Agency (EMA) and United States Food and Drug Administration (US FDA) submission from 2006 till December 2018. The commonest animal studies conducted included repeat-dose toxicity study along with toxicokinetic, local tolerance and immunogenicity assessments, while the least common included primary pharmacodynamic, pharmacokinetic, safety pharmacology and single-dose toxicity studies. Animal studies were designed based on pharmacology of the drug, disease condition and innovator studies. Studies mostly used EU-sourced reference products as a comparator. For biosimilars approved both in the US and European Union (EU), similar data packages were submitted to these regions. Despite the regulatory guidelines allowing waiver of animal studies based on analytical data, animal studies have been conducted for almost all the approved biosimilars in the US and EU. There is an increasing need to re-assess the relevance of animal studies to support regulatory approval of biosimilars. Stepwise assessment for biosimilarity and conducting animal studies only if required at the right instance based on residual uncertainties may assist in optimizing animal study requirement for biosimilar development.

A clinical comparative study of the management of chronic renal failure with Punarnavadi compound.

India like any other country is facing a silent epidemic of chronic renal failure (CRF)- a facet of the health transition associated with industrialization partly fuelled by increase in sedentary lifestyle, low birth weight and malnutrition. Increasing figures by many folds seen is posing a difficult situation to overcome with respect to economy and health of the working and earning population of the nation. There is an urgent need to explore, highlight new interventions and modify modifiable risk factors as a basis for treatment strategies to prevent the development and progression of CRF. The present study was taken up to evaluate the role of trial formulation tab. Punarnavadi compound in the management of chronic renal failure. This was an open clinical comparative study in controlled circumstances wherein 67 patients were studied for two months in three groups- Group A (allopathic control), Group B (ayurvedic control) and Group C (ayurvedic test). It was a multi-centric study; patients were registered from Anandababa charitable dialysis centre, Jamnagar, Kayachikitsa O.P.D. of I.P.G.T. and R.A. Jamnagar and P. D. Patel Ayurveda hospital, Nadiad. Results were assessed on 15 parameters using Students (paired) 't' test. Group A patients showed comparatively better results in eight parameters- weight, platelet count, serum urea, serum uric acid, serum sodium, potassium, chloride and total proteins. Parameter Hemoglobin% showed better results in Group B patients and in Group C patients comparatively better results in six parameters viz.- quality of life (breathlessness, weakness, general functional capacity), total count, serum creatinine and serum calcium - were observed. Throughout the study, trial drug tab. Punarnavadi compound did not show any adverse drug reaction. The results of this study will help in developing a cheap and safe treatment for the management of CRF.