Biotech: Facts and FiguresThis page houses a collection of common questions with answers, basic information, and other items of general interest to the biotech investor or enthusiast, even if they do not relate to one individual stock or drug.
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What are the biggest selling drugs in the world? What about most prescribed?
Check out these links at Drugs.com which have the top 100 biologics/drugs by sales and volume. [recently updated through 4q-2012 - bet you can't guess what drug they have at the top of the list!]
GEN tabulated the Top 20 Best Selling Drugs of 2012 and the Top 20 New Drugs Launched in 2012.
Visit the Big Red Biotech Blog for a list of the top-selling biologic drugs of 2011.
Visit DrugTopics.com for their list of 2010's Top 200 branded and generic drugs by sales and prescription numbers.
First World Pharma assembles the list of the best-selling drugs of all time.
Visit ModernMedicine.com for their index of Pharmacy Facts and Figures links.
Browse this infographic with top-selling drugs, including name, sales, company, structure, and indication (2009).
GEN tabulated the Top 20 Best Selling Drugs of 2012 and the Top 20 New Drugs Launched in 2012.
Visit the Big Red Biotech Blog for a list of the top-selling biologic drugs of 2011.
Visit DrugTopics.com for their list of 2010's Top 200 branded and generic drugs by sales and prescription numbers.
First World Pharma assembles the list of the best-selling drugs of all time.
Visit ModernMedicine.com for their index of Pharmacy Facts and Figures links.
Browse this infographic with top-selling drugs, including name, sales, company, structure, and indication (2009).
What are the stages of drug discovery and development? What studies, patients, and costs are involved?
For the answers, read the following articles:
Other useful articles and perspectives:
- Discovery and Preclinical Research & Development
- Drug Development Process: IND, Phase 1, Phase 2, Phase 3, and New Drug Application (NDA)
Other useful articles and perspectives:
- Phil Needleman's Ten Commandments of Drug R&D (Bruce Booth - LifeSciVC)
- How much is your IND going to cost? (PharmaDirections)
- FDA Calendar Glossary (BioPharm Catalyst)
- Clinical Trials: Facts and Figures (CISCRP)
Great Overviews on many topics - education videos from the Food and Drug Administration
- Accelerated Approval process
- Patents, Marketing Exclusivity, and the Orange Book
- Drug development for Rare and Orphan Diseases
- What will the FDA look like, and what will be its role in the future? [Politico panel discussion]
FDA pathways for submission and Product approval
505(j) aka Abbreviated New Drug Application (ANDA)
- Seeking generic approval of a product that is comparable to the branded, approval product that is already on the market (including formulation, dose, route of administration, and purity)
- Can be approved with designation to be automatically substitutable for the innovator product- ie, even though the doctor writes prescription for the innovator product, the pharmacy can give the generic drug instead
- Generally need to submit 3 month stability data, but no formal safety or efficacy data required
- "First to File" status can result in the generic company obtaining 6 months of exclusivity upon approval
- Changes to dose form, strength, route of administration, or formulation
- Generally need 12 month stability data for new formulation
- A bridging study is performed to compare the systemic levels of the new product compared to approved product
- Sponsor may conduct some sort of safety or efficacy trials, but can also sometimes access the safety and efficacy data of the reference product
- Unlike ANDA pathway, these approval are not usually deemed substitutable
- This pathway is faster and less expensive than NDA pathway
- Approved product can be granted 3 years of Hatch-Waxman exclusivity if the sponsor conducted some clinical trials
- Unlike NDAs, approval can be held up due to patent protection of the already approved product
- New molecular entity
- Requires full clinical safety and efficacy studies
Orphan Drug Designation
- "The Orphan Drug Act was enacted by Congress to provide financial incentives for the development of drugs for rare conditions (affecting less than 200,000 individuals per year) in the United States. The orphan designation is granted for a combination of a drug entity and an indication and therefore it can be granted for an existing drug with a new (orphan) indication. Applications are made to the Office of Orphan Products Development at the FDA and a decision or request for more information is rendered in 60 days. New Drug Applications designated as orphan drugs are exempt from user fees, obtain additional clinical protocol assistance, are eligible for tax credits up to 50% of research and development costs, and are granted a seven-year period of exclusivity upon approval. The FDA cannot approve the same drug for the same condition during this period of exclusivity, except in certain circumstances where a new product demonstrates superiority to the original treatment." Source: BPAX 2010 10k
- Note: this designation in no way involves the FDA expressing any opinion about the merit of the drug or therapy in question. This is generally a non-event for investors but sometimes leads to short-term pump and dump trading, especially in low quality biotech names
FDA Review classifications
- You'll here many terms related to the speed and classification of NDA's filed with the FDA, such as:
- Fast Track status
- Accelerated Approval - Click here to learn more!
- Priority Review
- Standard Review
- It is important to understand the distinctions, so please familiarize yourself with the detailed information and descriptions posted on the FDA website at this link
Facts, Figures, and General Resources
- Drug Development
--Complete set of FDA Guidance documents
--BioMed Tracker study of drug clinical trial success rate statistics (February 2011)
--Free database of pharmaceutical pricing and reimbursement data (ZenRx)
--How much is your IND going to cost? A humorous but factual post from PharmaDirections blog
--Where do those crazy drug names come from? (via CEN)
- Biosimilars - Biogenerics - Follow-on Biologics (FOBs)
--Article: "Biosimilars law in limbo" Brian Dorn, July/August 2011
--Article/Webinar: Physicians wary of biosimilars without clinical data, Fierce Biotech, August 2011
--Report from Scrip Reports entitled "Biosimilars, Biogenerics, and Follow-on Biologics" (2007)
--Report from Citeline entitled "Biosimilar Monoclonal Antibodies in the Pipeline" (September 2011)
- Cancer
--Lung Cancer Mutation Info - from Quest Diagnostics (nice background info on EGFR, KRAS, ALK)
--"The American Cancer Society estimated that in 2010 approximately 1,529,560 new patients in the United States would be diagnosed with cancer and that there would be approximately 569,490 patient deaths attributable to cancers." (OGXI 2010 10k)
--"Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with multiple myeloma and approximately 20,000 new cases are diagnosed annually. Worldwide, more than 180,000 people are living with multiple myeloma and approximately 86,000 new cases are diagnosed annually" (ONXX PR 12/2010)
--Bladder Cancer - click to download introductory slide deck
--Webinar: "Getting the most PoC [proof of concept] data in Phase I cancer studies" - from Ryan McBride of Fierce Biotech
--"Speak Up: 8 Words & Phrases to Ban in Oncology!" article by Dr. Robert Miller.
--"Drugs Approved for Leukemia" (National Cancer Institute)
--Top 10 Best-Selling Cancer Drugs of 2013 (FiercePharma)
- Diabetes
--Novo Nordisk presentation "Diabetes treatment tomorrow" 5/2011
--Chinese Diabetes Epidemic - now affects 10% of adult population 3/2012
- Other
Rare Diseases facts and figures (Global Genes)