InstructorRoyed Training
TypeOnline Course
Price$490 / 34300 INR.
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Biosimilar Strategic Management Course

Introduction

Features

Core Learning Areas

Related Courses

About Pharma Management

Add on Certification

Royed Training’s Advanced Certification in Biosimilar Strategic Management is a specialized, in-depth training program designed to provide a 360-degree perspective on the biosimilar product journey — from scientific development to global regulatory approval, production optimization, and ultimately, successful commercialization and market access.

With the biosimilar market evolving rapidly and becoming a cornerstone of global biopharmaceutical strategies, there is a growing demand for professionals who can navigate the complex, multi-functional landscape of biosimilar strategic planning. This course fills that gap by offering practical, real-world learning combined with interactive simulations and case-based scenarios.

Who should attend this course? 

  • Biopharmaceutical professionals in R&D, Regulatory Affairs, Market Access, Business Development
  • Strategic Planners, Project Managers, and Brand Managers
  • Entrepreneurs or consultants involved in biosimilar businesses
  • Graduates seeking specialized skills in biopharma strategy

Course Snapshot

  • Course Code: RYD-131
  • Title: Advanced Certification in Biosimilar Strategic Management (ACBSM)
  • Type of the course: Self paced Online Course. Hence this course can be accessed online across anywhere 24×7. Moreover, you can attend the course at your convenience in your flexible time. For example, if you want to attend the session at 11 pm at night, you can do that.
  • Course Duration : 1 Month
  • Course Certification: Certificate will be provided at the end of the successful completion of the course.

Course Features of Biosimilar Strategic Management

  • 100% Online and Self-Paced: Access the course anytime, anywhere with complete flexibility to learn at your own pace.
  • Biosimilar Product Class Training: Detailed modules covering various biosimilar classes like monoclonal antibodies, insulins, erythropoietin, growth hormones, etc., and how their development and approval pathways differ.
  • Real-World Case Studies: Learn through actual biosimilar success and failure stories across regions and product categories to understand strategic challenges and winning models.
  • Hands-On Simulations: Engage in interactive simulation exercises — including regulatory planning, pricing strategy, and launch execution — designed to mimic real-life business scenarios.
  • Regulatory Intelligence Coverage: Stay updated with comprehensive insights into biosimilar regulations in US, EU, WHO, GCC, LATAM, ASEAN, and emerging markets.
  • Strategic Planning Tools: Downloadable frameworks and tools for regulatory planning, market access assessment, pricing models, and launch readiness.
  • Expert-Curated Modules: Content developed and reviewed by seasoned professionals from biopharma regulatory, manufacturing, and commercial domains.
  • Course Progress Tracker and Analytics: Personalized dashboard to monitor learning progress, quiz performance, and module completion.

Key Learning Highlights:

  • Biosimilar Development: Explore the scientific, technical, and clinical requirements for biosimilar development including analytical characterization and comparability exercises.
  • Regulatory Pathways: Deep dive into global regulatory frameworks such as US FDA, EMA, WHO, and emerging markets for biosimilar approvals.
  • Production Strategy: Understand manufacturing scale-up, QbD, and cost-effective production planning for biosimilars.
  • Market Access & Strategic Planning: Learn real-world techniques in pricing, tendering, HTA evaluations, payer engagement, and market differentiation strategies.
  • Business Simulation and Case Studies: Apply learning to simulated launch scenarios, regulatory hurdles, and go-to-market challenges.

Career in Biopharma Global Business

One of the fastest growing industries in is biopharmaceuticals. Hence the job market offers multiple opportunities for life science professionals as biotech companies work everyday to create successful products and place them in the marketplace. In biopharmaceutical industry scientists and researchers are key people who always preferred because of their biopharma subject knowledge. While these individuals have the academic and scientific background, they may not have the strategic management skills to manage biopharmaceutical business. Hence, this course provides necessary training to skill up the biopharmaceutical professionals.

In biopharmaceutical industry, strategic manager oversee the process of discovery, development and commercialization. They determine the biopharmaceutical products scope, timelines, budget and procurement, market access, regulatory, quality controls, marketing strategies, etc.

What are the areas biopharma global business professionals can make a career in biopharmaceutical company?

Biopharmaceutical Global Business Professionals will have option to join or work in following departments :

  • R&D Project Management
  • Strategic Management
  • Market Access
  • Global Pricing
  • Regulatory Affairs
  • Business Development
  • Licensing Department (Inlicensing or Outlicensing)
  • Brand Management
  • Marketing and Sales Management

Specific Knowledge of the various business regions is important for biopharmaceutical business management

There is no doubt that the biopharmaceutical industry is growing at a rapid pace. In fact Biologic is the future of medicine. However there is a rising concern over the safety and efficacy. Hence, the major objective of the biopharmaceutical management professionals is to learn various regional regulatory and business development knowledge. In fact, regional biopharma knowledge will help them to become successful in international business management. Moreover, the biopharma business development landscape is evolving and changing every other day. Biopharma management professionals must have thorough knowledge about the updated regulations. Sound regulatory knowledge helps them to take strategic decisions effectively. Therefore, this course is an ideal choice for the biopharmaceutical management course which covers various domains.

Add on Certification

  • The participants of Global Business Registrant will get two add-on certifications.
  • Hence participants can choose add on courses of any 1 month or 1 week / 3 Days certification course. One can choose the desired course from the following course list. 
  • Participants can activate the add on course anytime during 1 year active course duration.
  • On completion of the add-on course, participants will be issued a course certificate. Hence, apart from the biopharma global management certification, participants will receive 2 add-on course certificates without any additional cost.
  • You can activate this add on course anytime during the active 1 year course tenure.
Section 1Biosimilar R&D Process & Introduction to discovery, development to commercialization process
Lecture 1Biopharma R&D Process & Introduction to discovery, development to commercialization process
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 5Basic concept and understanding of the Generic Drug
Lecture 6Abbreviated New Drug Application (ANDA) 
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 8505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 9Vaccine development and approval Process
Lecture 10Handling of orange book
Lecture 11Purple Book: Significance | Searching | Assignments
Section 2Biosimilar Commercialization Stategic Planning
Lecture 12Biosimilar Approval and Patent Management | Strategic Pathway of Patent Negotiation and Litigation in Biosimilar Approval | Patent Dance | FAQs on Biologic Patent Management 
Lecture 13Biosimilar launch case study | Patent Dance Framework
Lecture 14Biosimilar Launch Framework 
Lecture 15Biosimilar 180 Day Notice 
Lecture 163(A) List | Significance | Importance | How to interpret
Lecture 17Steps to win over innovator patents | Step wise planning 
Lecture 18Biosimilar Launch Project Roadmap with defined stages of project
Lecture 19Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessments 
Lecture 20Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation  
Lecture 21How to work on RPS’s Patent | Walkthrough | Case Study
Lecture 22Biosimilar Launch Project With Milestones
Lecture 23Analysis of Biologic Patents | Work Assignments
Lecture 24Biologic Patent Insight Worksheet
Lecture 25Patent Thickets | Concept | Implication | Case Based Learning 
Section 3Training on different classes of Biosimilar
Lecture 26Introduction : Biopharmaceuticals
Lecture 27Classification of Biopharmaceutical 
Lecture 28Important Concept regarding Biopharmaceuticals
Lecture 29Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 30Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs
Lecture 31Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 32Global Biopahrma Market Trends
Lecture 33Recombinant protein
Lecture 34Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 35Monoclonal Antibodies
Lecture 36Synthetic Immunomodulators
Lecture 37Production of Monoclonal Antibodies
Lecture 38Cytokines
Lecture 39Interferon
Lecture 40Erythropoiesis-stimulating agent
Lecture 41Vaccine development and approval Process
Lecture 42Biosimilar Development Process
Lecture 43Strategic Consideration for Biosimilar Development 
Lecture 44Bio-Manufacturing Process Information
Lecture 45Studies required for approval of biosimilar
Lecture 46REMS Strategic Planning 
Section 4Biosimilar Strategic (Add on Sessions)
Lecture 47Patents Vs. exclusivity 
Lecture 48Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 49Orphan Drug Designation 
Lecture 50USFDA expedited programs
Lecture 51Advance study on Para IV Filing
Lecture 52Para IV Notices
Lecture 53Evergreening - Patent Life Extension Strategies
Lecture 54Pay For Delay Strategy
Lecture 55Compulsory Licensing
Lecture 56Licensing & Technology Transfer
Lecture 57In-Licensing Vs. Outlicensing
Lecture 58LOE Strategies for Innovator Brands with case study
Lecture 59Drug Repurposing
Lecture 60Advance understanding of the portfolio Management 
Section 5Advance Biosimilar Regulations and Submission Management
Lecture 61505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 62Advance Learning on 505B2 Pathway
Lecture 63Chemistry, Manufacturing & Controls 
Lecture 64Common Technical Document (CTD)
Lecture 65Introduction to Electronic Common Technical Document (ECTD)
Lecture 66Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 67Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 68Importance of effective dossier management
Lecture 69Certificate of Analysis
Lecture 70Prior Approval Submission 
Lecture 71NCE Vs. 505b2 application - Case Based Learning 
Lecture 72Discussion on 85 common deficiency in CTD submission dossier
Lecture 73Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 74PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 75Bioequivalence Study | Study design | Different types of BE Studies
Lecture 76Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalization | Confidence interval acceptance criteria
Lecture 77Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 78Data Integrity issues in Pharmaceutical Industry
Section 6Biosimilar Market Access & Pricing - Forecasting - Formulary Placement of brands
Lecture 79Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 80Market Access Functions : Role and Responsibilities | Key Job Areas | Understanding Job Description
Lecture 81Market Access Strategic Planning
Lecture 82Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization
Lecture 83Indication Prioritization Case Study
Lecture 84Market Access Value Dossier : What it is | Significance | Components | What to include
Lecture 85AMCP Market Access Value Dossier Preparation
Lecture 86Drug Pricing Methodologies
Lecture 87Sales Forecasting in Life Science Industry
Lecture 88New Product Forecast Algorithm
Lecture 89Patient Based Forecasting Model | Applying more filters and variables
Lecture 90Prescription Based Forecasting Model | Differences between Patient Based and Prescription Based Forecasting Model | Which model to use and when?
Lecture 91Prevalence Vs. Incidence Model
Lecture 92EPI Based Forecasting | Sales Based Forecasting | When and where to apply which forecasting model
Lecture 93Sales Forecasting Tools | New Product Forecasting | In Market Forecasting
Lecture 94Market Size Assignment 1 [Oncology Brand] - Applying sales forecasting tools to carry out next 6 years sales forecast | Excel Based Model
Lecture 95Market Size Assignment 2 [Asthma Brand] - Applying sales forecasting tools to carry out multiple years sales forecast | Excel Based Model
Lecture 96Formulary Placement | Different Tiers | How to classify the medication in different tiers | Formulary negotiation process | Rebates | Copay differential | Step-edits | Case Simulations - teasers
Lecture 97Patient Based Model Vs. Patient Flow Model | Critical Differences in Model | Concept of Black Box in Patient Flow Model | Application of both model
Lecture 98Concomitancy and polypharmacy | How it alter the basic forecasting algorithm | Practical Working | Comorbidity
Lecture 99Forecasting Techniques | Simple Conjoint-type Models | Zipf's Law | Simple Elasticity Model | The Bass Model |Simple Extrapolation
Lecture 100Simulation on Bottom-up forecasting
Lecture 101Assessment on Bottom-up forecasting
Lecture 102Oncology Brand Forecasting
Lecture 103Authorized Geenric
Lecture 104Branded Generics | Differences from Authorized and Unbranded Generics | Strategic planning for formulary placement 
Section 7Biopharma Business Development | Licensing
Lecture 105Training on Basic Finance  |  Understanding Financial Statment | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 106Moving Average | Moving Annual Total | YTD | How to calculate 
Lecture 107Compound Annual Growth Rate | CAGR Calculation
Lecture 108Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 109Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 110Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 111Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 112Numerical SWOT Practical training
Lecture 113Modelling and Deal Valuation - Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 114Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 115Forecasting : Tools and Techniques
Lecture 116Market Sizing & Forecasting Case Study
Lecture 117Royalty Management - Royalty structuring | Royalty Calculation Method| Tiered Royalties | Terms | Royalty Reductions | Royalty Stacking - Concept and Calculation | Minimum Annual Royalties | Reach through royalties
Lecture 118Average Royalty Rate
Lecture 119Factor affecting the Royalty Rate in Pharmaceutical and Biopharmaceutical Deal
Lecture 120Distribution Licensing | Geography | Indication Splitting | Exclusive and Non-Exclusive Licensing | Sub Licenses
Lecture 121Acquisition in Pharma  | Product Acquisition| Company Acquisitions| Steps in acquisition | Financing acquisition deals | Trademark Assignment Process
Lecture 122Joint Ventures in Pharmaceutical and Biopharmaceutical Industry
Lecture 123SPECIAL PURPOSE VEHICLES (SPV)
Lecture 124Indication Splitting | Concept | Implementation feasibility analysis 
Lecture 125Types of Deals from Discovery to Commercialization
Lecture 126What are the fundamental areas of business development
Lecture 127Licensing Term Sheet | Content Structuring | Sample Term Sheet
Lecture 128Licensing Payment Scheduling: Different Types
Lecture 129Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 130Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 131Negotiation Skill Training for BD personnel | Mind Mapping Tools | Practical Case Based Learning | Do and Don’ts in Pharma Business development Negotiations | Role of Scribes
Lecture 132Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Lecture 133Types of Strategic Alliances: Unilateral technology licensing | Cross technology licensing | R&D contracts | R&D collaborations | Minority-equity-based R&D alliances | JV | Manufacturing and marketing agreements | big pharma firms with dedicated biotechnology firms 
Lecture 134Benchmarking | Benchmarking through consortium | How to use benchmarking for drug discovery development projects 
Lecture 135DCF Calculation : Concept and Calculation - Step by step understanding
Lecture 136Net Present Value (NPV) method : Calculation
Lecture 137Risk-Adjusted Discount Rate Method - Calculation | Concept of Risk Premium 
Lecture 138Valuation Metric - P/E Ratio and EPS : Calculation
Lecture 139Comparable Company Analysis method : Calculation