Eyes on Follow-On Biologics

Drug Approvals Sliding and Patent Cliff Approaching

Drug development is a painfully slow, costly, and risky business.  It’s a hit or miss and the odds can be a multi-billion dollar question.  In 2010, the FDA approved 21 new drugs (new molecular entity and biologics), slightly down from 25 drugs in 2009.
These 21 drugs from the FDA database (NDA Chem Type 1 and BLA) are:

Company Brand Name Active Ingredients
ACORDA AMPYRA DALFAMPRIDINE
NOVO NORDISK INC VICTOZA LIRAGLUTIDE RECOMBINANT
GENENTECH ACTEMRA TOCILIZUMAB
SHIRE HUMAN GENETIC VPRIV VELAGLUCERASE ALFA
AUXILIUM PHARMS XIAFLEX COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
CHEMISCH FBRK KRSSLR ASCLERA POLIDOCANOL
ORPHAN EUROPE CARBAGLU CARGLUMIC ACID
BAYER HLTHCARE NATAZIA DIENOGEST; ESTRADIOL VALERATE
GENZYME LUMIZYME ALGLUCOSIDASE ALFA
AMGEN PROLIA, XGEVA DENOSUMAB
SANOFI AVENTIS US JEVTANA KIT CABAZITAXEL
VISTAKON PHARMS LLC LASTACAFT ALCAFTADINE
MERZ PHARMS Xeomin incobotulinumtoxinA
LAB HRA PHARMA ELLA ULIPRISTAL ACETATE
NOVARTIS GILENYA FINGOLIMOD
SAVIENT PHARMS KRYSTEXXA PEGLOTICASE
BOEHRINGER INGELHEIM PRADAXA DABIGATRAN ETEXILATE MESYLATE
CEREXA TEFLARO CEFTAROLINE FOSAMIL
SUNOVION LATUDA LURASIDONE HYDROCHLORIDE
THERATECHNOLOGIES EGRIFTA TESAMORELIN ACETATE
EISAI INC HALAVEN ERIBULIN MESYLATE

I can imagine even just “one” more drug being added to the list can mean huge revenue to a company, hope to patients, and rewards for collective efforts from hundreds, if not thousands, of people involved during the drug development and evaluation processes.  So the declining drug approval number (from 25 to 21) is a warning sign to the industry.  To make matter worse, Nature news reported that looking forward, drug companies will encounter the most fierce competition from the generic drug makers in 2011 and 2012 because many blockbuster brand name drugs will face patent expiration.  Together, thinning drug pipelines, patent cliffs, and stricter regulatory policies all put heavy pressure on drug companies.  How will the drug companies react?

Biosimilars = Follow-On Biologics = Me Too Drugs

When the patent of a brand-name drug from the pharmaceutical/biotech company XYZ expired, other companies are allowed to copy the formula to make the same drug, called generics, to sell for a lot less and then to compete with THAT brand-name drug.  Imagine a secret recipe is published from a world-renowned chef in a three star Michelin restaurant, so now you and I and everyone can follow the instruction to make the same food, well, in theory.  In order to not lose much revenue after patent expiration, many drug companies have gradually stepped into generics market and have gone to lawmakers for help.  Recently, Merck & Co shook hands with contract researcher Parexel International Corp to develop biosimilars.  Biogen Idec Inc. also plans to expand into biosimilars as they will provide meaningful revenue streamSimilar interests from several big pharmaceutical companies were also expressed in the January’s JP Morgan healthcare conference in San Francisco.  It seems there will be a stronger competition in the years to come.

Until next post, keep on reading and writing!

Advertisements

About fdabiomed
I like to read, organize, and write about biomedical related topics. I am passionate to learn new things, particularly news related to the Food and Drug Administration's decision and announcement.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: