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Home | Novel Biologics & Biosimilars



NOVEL BIOLOGICS & BIOSIMILARS

Paras Biopharmaceuticals' Novel Biologics and Biosimilar Pipeline & Technologies



Novel Biologics and Biosimilars Pipeline

Paras Biopharma Novel Biologics

Paras Biopharma Novel Biologics approach and portfolio pipeline comprises of
Biologics for Rare & Orphan Diseases and Novel applications in Multiple Myeloma,
Respiratory, Gout, Pulmonary Arterial Hypertension, Osteoarthritis, and Knee
Fibrosis.

Multiple Myeloma Respiratory Gout Pulmonary Arterial Hypertension Osteoarthritis
Knee Fibrosis

Paras Biopharma Biosimilars

Paras Biopharma Biosimilar approach and portfolio pipeline comprises of unique
biosimilars that have niche indications, low competition, high value and growing
market opportunity, and low risk for development. Product pipeline includes
biosimilar candidates of Oncology, Osteoporosis, Rheumatoid Arthritis, and
Metabolic Diseases.

Oncology Osteoporosis Rheumatoid Arthritis Metabolic Diseases

Biosimilar Overview

Paras Biopharmaceuticals is committed to innovation of high-quality products and
technologies. The Company has developed robust biosimilars development
technologies for the following medical areas:



Oncology products for: multiple myeloma, platelet disorder, and tumor lysis
syndrome.

Biosimilar Technologies/Product Pipeline

Paras Biopharma Product / Biosimilars Target Disease Brand Name(INN Name)
Description Technology Platform PB (Osteo)-1010 Osteoporosis Terishield™
(Teriparatide) Biosimilar candidate to Forteo® Diabrid™Technology /
NobleCleav™Technology PB (RA)-2010 Rheumatoid Arthritis IL-KTM™(Anakinra)
Biosimilar candidate to Kineret® High Expression Technology PB (MDT)-3010 Type I
and II Diabetes Asplin™(Insulin Aspart) Biosimilar candidate to Novolog® Diabrid
Technology / NobleCleav™Technology PB (CT)-4020 Oncology (Platelet Disorders)
Romi-Multiplat™ (Romiplostim) Biosimilar candidate to Nplate® Biomultifold™
Technology PB (CT)-4030 Oncology (Tumor Lysis Syndrome) Raspa™ (Rasburicase)
Biosimilar candidate to Elitek® High Expression Technology

Disclaimer

Products under patents are part of our research projects. These products may be
offered only in those countries where patents have expired.

For the latest status, please contact Paras Biopharmaceuticals Finland Oy.

Forteo®, Kineret®, Elitek®, Nplate®, and Novolog® are registered trademarks
of/marketed by Eli Lilly, Sobi/Amgen, Amgen, Sanofi and Novo Nordisk
respectively. *Source GlobalData

Paras Biopharma Product / Biosimilars Target Disease Brand Name(INN Name)
Description Development Stage PB (RA)-2020 Rheumatoid Arthritis
Ceras-peg™(certolizumab) Biosimilar candidate to Cimzia® Under development PB
(CT)-4040 Multiple Novel Applications IL-MTM™ Biobetter candidate to IL-1 RA
Under development PB (CT)-4010 Oncology (Multiple Myeloma) IL-BTM™ Biobetter
candidate to IL-1 RA Under development PB (OA)-5010 Osteoarthritis IL-OTM™
Osteoarthritis patch of IL-1 RA Under development

Disclaimer

Products under patents are part of our research projects. These products may be
offered for further development only in those countries where patents have
expired. For the latest status, please contact Paras Biopharmaceuticals Finland
Oy.

Cimzia® is a registered trademarks of/marketed by UCB. *Source GlobalData

Unique Features

Paras Biopharmaceuticals innovative technology platform, along-with other
associated process technologies, enables a very high and economical way to
develop biosimilars for scale-up production.

The Paras Biopharmaceuticals’ Team has successfully developed a multiple
biosimilar in its pipeline for “Rare & Orphan diseases” which are now available
in the company’s portfolio for partnership.

Biosimilars Pipeline & Technologies

Development of Recombinant Expression Systems & Process Technologies for
Biologics & Biosimilars:

Paras Biopharmaceuticals is actively engaged in research & development and is
offering partnership for further development (including clinical development) on
the following biosimilars:

 * Recombinant Teriparatide (Forteo®Biosimilar).
 * Recombinant IL1-RA / Anakinra (Kineret®Biosimilar).
 * Analog Insulin Aspart.
 * Recombinant Romiplostim (Nplate®Biosimilar).
 * Further biologics are in the pipeline.

Due to its own technologies, Paras Biopharmaceuticals has achieved efficient and
cost-effective ways which would help in the efficient production of some high
value biosimilars. This development is based on Paras Biopharmaceuticals'
proprietary technology platform which includes Diabrid®, Noblecleav®,
Biomultifold® & Cytofold StructQuant® technologies.

Forteo®, Kineret® and Nplate® are registered trademarks of/marketed by Eli
Lilly, Sobi Sweden and Amgen USA respectively * Source GlobalData

Biosimilars Technologies/Product Pipeline

Paras Biopharmaceuticals Biosimilar pipeline Terishield™ IL-KTM™ Asplin™
Reference Product Forteo® Kineret® Novolog® INN Teriparatide Anakinra Insulin
Aspart Major Approved indications Postmenopausal Osteoporosis Rheumatoid
Arthritis, CAPS#, DIRA* Diabetes Mellitus 2020 Global sales* $ 1076m $ 220m $
4385m Development stage Scale-up production and comparison Scale-up production
and comparison Pre-clinical (high expression achieved)

Disclaimer

Products under patents are part of our research projects. These products may be
offered for further development only in those countries where patents have
expired. For the latest status, please contact Paras Biopharmaceuticals Finland
Oy.

Forteo®, Kineret®, and Novolog® are registered trademarks of/marketed by Eli
Lilly, Sobi/Amgen, and Novo Nordisk respectively * Source Globaldata

Paras Biopharmaceuticals Biosimilar pipeline Romi-MultiPlat™ Raspa™ Ceras-Peg™
Reference Product Nplate® Elitek® Cimzia® INN Romiplostim Rasburicase
Certolizumab-pegol Major Approved indications Immune Thrombocytopenia Mgmt. of
plasma uric acid levels in oncology patients TNF blocker indicated for
Rheumatoid Arthritis and others 2020 Global sales* $ 920m $ 170m $ 210m 2025
Sales estimates* $ 964m $ 314m $ 1847m Development stage Scale-up production &
biosimilarity/ Pre-clinical Under development (high expression achieved) Under
development

Disclaimer

Products under patents are part of our research projects. These products may be
offered for further development only in those countries where patents have
expired. For the latest status, please contact Paras Biopharmaceuticals Finland
Oy.

Nplate®, Elitek®, and Cimzia® are registered trademarks of/marketed by Amgen,
Sanofi, and UCB respectively * Source Globaldata

PB (Osteo)-1010 (Biosimilar candidate to Forteo®)

Osteoporosis

Brand Name:
Terishield™ INN:
Teriparatide Reference Product:
Forteo®

 * PB Osteo-1010 is a recombinant form of the parathyroid hormone whose
   molecular weight of the final Drug Substance is 4117 g/mol.
 * PB-osteo-1010 has been developed for use in post-menopausal women with
   Osteoporosis possessing a high risk of fracture or with a history of
   Osteoporosis fracture.
 * The National Osteoporosis Foundation estimated that in 2020 61 million people
   experienced the effects of Osteoporosis or Osteopenia. Women are affected in
   greater numbers as they have a lower peak bone density.
 * Paras Biopharmaceuticals has successfully achieved a unique and novel process
   to obtain high expression.

Forteo® is a registered trademark of/marketed by Eli Lilly.

PB (Osteo)-1010 (Osteoporosis)

Product Status:

 * SDS-PAGE high Expressions
 * Separation and purification of Diabrid™ achieved
 * Confirmation through mass spectrometry

Technology Status

 * Soon ready to be out-licensed with scale-up production established.
 * Recombinant state E. Coli clone exhibit high expressionof the osteoporosis
   product (EM@39000-Paras Rights Reserved).
 * SDA-PAGE-Gel image showing marker (lane 1), homogenization broth (lane 2) and
   separation of product in Diabrids (lane 3).
 * Multiple batches carried out at small & large scales.
 * Processes optimized at scale-up level.
 * Biocomparability methods established.
 * Extensive product characterization done.
 * Biosimilarity established.

PB (RA)-2010 (Biosimilar candidate to Kineret®)

Rheumatoid Arthritis

Brand Name:
IL-KTM™ INN:
Anakinra Reference Product:
Kineret®

 * PB-RA-2010 is (originator soon to be off patent) a recombinant human
   Interleukin-I receptor-antagonist protein.
 * PB-RA-2010 is a biosimilar candidate molecule that works by blocking the
   biological activity of the IL-I receptor. IL-I is a key mediator of
   inflammation and a driver of auto inflammatory diseases in both adults and
   children.
 * PB-RA-2010 is a recombinant non-glycosylated version of IL-IRA produced in
   genetically modified E. Coli using recombinant DNA technology. It consists of
   153 a.a.and possesses a molecular mass of 17.3 KDa.
 * Paras Biopharmaceuticals Finland Oy has successfully achieved a very high
   expression of the Biosimilar Rheumatoid Arthritis candidate.

Kineret® is a registered trademark of/marketed by Sobi/Amgen.

PB (RA)-2010 (Rheumatoid Arthritis)

Product Status:

 * SDS-PAGE high Expressions
 * Separation and purification of Diabrid™ achieved
 * Confirmation through mass spectrometry
 * Very high yield of product achieved –multiple grams per liter yield of
   purified material

Technology Status

 * Technology ready to be out-licensed for scale-up production.
 * Recombinant state E. Coli clone exhibit expression of the Rheumatoid product
   (EM@39000-Paras Rights Reserved).
 * SDA-PAGE-Gel image showing marker (lane 1), homogenization broth (lane 2) and
   separation of product (lane 3). Lanes 4 & 5 show the purified product.
 * Mass spectrometry (MS) data shows confirmation of the correct product.
 * Multiple batches carried out at small & large scales.
 * Processes optimized at scale-up level
 * Extensive product characterization done
 * Biocomparability methods established
 * Biosimilarity established

PB (MDT)-3010 (Biosimilar candidate to Novolog®)

Diabetes (Metabolic Disorders)

Brand Name:
Inspart™ INN:
Insulin Aspart Reference Product:
Novolog®

 * Paras Biopharmaceuticals Finland Oy has successfully developed a high
   expression and have Analog Insulin Biosimilar production clones.
 * Rapid acting analog "Aspart" is produced with Paras Diabrid™ Technology.
 * The process for the production of insulin "Aspart" is currently being
   prepared for worldwide PCT patent submission. These technological innovations
   by Paras Biopharmaceuticals reduces the costs of industrial production of
   Insulin "Aspart" achieving higher economic advantages.

Novolog® is a registered trademark of/marketed by Novo Nordisk.

PB (MDT)-3010 (Diabetes)

Product Status:

 * SDS-PAGE high Expressions
 * Mass spectrometry: Confirmation of N-& C-Terminal, and AA sequence

Technology Status

 * Soon to be available for licensing within scale-up production
 * Recombinant state E. Coli / S. cerevisae clone exhibits expressions of the
   metabolic disorder treatment (PB (MDT)-3010) (EM@39000 -Paras Rights
   Reserved)
 * SDA-PAGE-Gel image showing marker (lane 1), homogenization broth (lane 2) and
   separation of metabolic disorder treatment product (lane 3)
 * Multiple batches carried out at small & large scales
 * Processes optimized at scale-up level
 * Biocomparability methods established
 * Extensive product characterization done
 * Biosimilarity established

Advantages of Biosimilars

Salient Features Small Molecule Biosimilars (follow-on biologics) Novel
Biologics Market entry barriers Low High -(Technology and scientific knowhow
available with Paras Biopharmaceuticals) High Product development costs Low
Medium Very High Price advantage Low -(high discount on innovator molecule
price) High -(low discount on reference product price) N.A. USPs First to market
and low price Low competition -(Niche product dev. capabilities by Paras
Biopharmaceuticals) Differentiated therapies;

Paras Biopharmaceuticals Business Model

Paras Biopharmaceuticals has generated an authentic and well-characterized
biosimilars production process using its Diabrid®, NobleCleav® & Biomultifold®
technologies

Company’s business model works on the following features:

1. In-house biosimilar development has established an economical production
process & extensive characterization.

2. Collaboration with (bio)pharmaceutical companies for clinical development /
commercialization.



Biosimilar Market Insights
 * As per one estimates, global biosimilars market is expected to reach US$ 35,7
   bn by 2025 from US$ 11,8 bn in 2020 at a CAGR of 24.7%.
 * Potential savings in use of biosimilars have been anticipated to cross US$
   100 bn by 2020.
 * Recombinant non-glycosylated proteins accumulated a significant revenue share
   for the biosimilars market in 2018 and the value is likely to grow at a 26.1%
   CAGR through 2025.
 * From 2015 to 2023, approx. US$ 122,7 worth of biologics be off–patent opening
   new and major opportunities.
 * European Authorities have taken a lead on approval of Biosimilars.
 * In 2012 or so, 16 Biosimilars were approved in Europe. The recommendations
   for approval of biosimilars has reached 77 by Feb 2021.
 * New Law in USA-Biologics Price Competition and Innovation Act (enacted in
   2010). Based on this law, the US-FDA has the authority to approve similar
   versions of biologic products (“biosimilars”).
 * US-FDA issued draft guidelines for biosimilars approval (2012).

Osteoporosis Market Insights
 * Osteoporosis is often called the "silent disease" because bone loss occurs
   without symptoms. It is characterized by low bone mass and deterioration of
   bone tissue, leading to bone fragility and a consequent increase in risk of
   fracture.
 * As per International Osteoporosis Foundation census, more than 200 million
   people in the world are affected by osteoporosis, of which about 80% are
   women.
 * Osteoporosis represents an implacable epidemic growing rapidly in regions of
   North America, Europe, and Japan.
 * Osteoporosis prevalence is expected to increase due to the general aging
   population. In addition to increasing awareness, diagnosis and treatment.
 * By 2020 or so, the total male and female osteoporosis population was forecast
   to increase by 16.0% to reach 188 million patients across the seven major
   markets alone.
 * There are four Osteoporosis Drug Class (Bisphosphonate, SERM, PTH and
   Calcitonin) market.
 * Top Osteoporosis Drug Brands are –FORTEO, PROLIA, Fosamax, Actonel, Reclast,
   Boniva, Evista, Viviant/Conbrizaand Miacalcin.
 * A rapid uptake of Forteo/Forsteoand Prolia make these two products the most
   significant market drivers of osteoporosis therapeutics market.

Diabetes & Insulin Market Insights
 * By 2030, there will be 436 million diabetics worldwide.
 * Diabetes is a chronic disease leading to life-long use of medicines.
 * Diabetes markets to grow as prevalence of over-weight and obesity is
   increasing rapidly.
 * Diabetes affects more than 32 million Americans today. These numbers are
   expected to grow to 53 million in 2025.
 * The annual budgets of medical and indirect society costs are expected to rise
   from 300 Billion USD to 515 Billion USD in 2025.
 * Demand for Diabetes products are growing as life expectancy is also growing.
 * By 2050, life expectancy is expected to increase and reach over 80 years.
   This will further fuel growth and needs of diabetes products globally.
 * Insulin markets are growing with sustained double-digit growth.
 * Demand of modern Insulins is growing more rapidly, and modern Insulins are
   replacing normal Insulin and animal Insulins.
 * Total Sales of Diabetes products are expected to cross sales of 32 billion
   dollars a year.
 * A major opportunity lies in the emerging markets for insulin, especially in
   the BRIC nations.





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 * Partnerships
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 * Advisory Board
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SALES

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 * Cytoplasmic Protein Folding Technology
 * Advantages of Paras Technology

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