Sandoz Aims to Launch Biosimilar Version of Enbrel

Sandoz, a generic subsidiary of Novartis and an industry leader in the development of follow-on biologics, is launching a Phase III clinical trial of a biosimilar version of Amgen’s Enbrel (etanercept).  Enbrel fights autoimmune diseases by acting as a tumor necrosis factor (TNF) inhibitor to treat inflammatory conditions like rheumatoid arthritis and psoriasis.  Generic production of biologics is tricky because biologics are proteins derived from cells of living organisms and cannot be perfectly duplicated.  Instead, Sandoz hopes to demonstrate the biosimilarity of its product to Enbrel. The new clinical trial will investigate the ability of the molecule to elicit the same immune response in patients with moderate to severe plaque-type psoriasis.  Safety and efficacy will also be determined. Continue reading


Pfizer and Sun Settlement: Bad Omen for “At Risk” Generics Launches

Christie Shilling
By Christie Shilling,
Research Analyst

Once upon a time, a generics pharmaceutical company launched a generic version of another company’s branded product before patent expiration. Many years passed, with both companies in court fighting over the patent’s validity, until one summer day they finally reached a settlement. The generics company was dismayed at the amount it would have to pay the branded company, but it agreed anyway for fear that a full court decision would demand even more money. From that day forward, the generics company realized it maybe should be a little more cautious about launching its version before the patent for the original ran out. Continue reading


Less Is Definitely Not More for Counter-Generics Strategies

Christie Shilling
By Christie Shilling,
Research Analyst

We have a running joke among the researchers at Cutting Edge Information.  Many of the key findings from our research can be boiled down to one phrase: Start Early.  Our usual advice for pharmaceutical companies is to start planning as early as possible for all tasks.  Planning for patent expiration and generic market entry is no exception.  Companies should begin to plan as early as possible — even as far out as 7 to 10 years prior to loss of exclusivity — to successfully counter the threat of generics.  Yet teams in charge of counter-generic strategy consistently wait until only two years before patent expiry to start planning.  Waiting this long, however, means that many companies won’t have time to implement some of the best tactics before generics hit the market.  Continue reading


Counter-Generics Strategies

With patents expiring right and left, pharmaceutical companies are looking for every possible tool to slow revenue losses. Counter-generic strategies are one method to maintain market share, however temporary. Even a period of six months when no generic versions can enter the market, as pediatric exclusivity grants, can mean a difference of millions or even billions of dollars. Continue reading



Portfolio Managers Need to Think at Least 10 Years Ahead

By Michelle Vitko,
Research Analyst

The earlier pharmaceutical companies begin mapping out their portfolio management options, the more strategies will be available to them and the more success they will have in general. In fact, a senior director at a top 50 pharma company that I recently spoke with told me Continue reading



Pharmaceutical Brand Defense Strategies: Patent Litigation

By Ryan McGuire,
Senior Research Analyst

This is the second installment in a blog series focusing on counter-generic strategies. Read the first part here.

Litigation is a natural response for pharmaceutical and biotechnology companies that find their patents being challenged by generics manufacturers. After all, the industry relies heavily on strong intellectual property rights for its continued survival. Continue reading


Defense Against the Patent Cliff

This is the first entry in a series that will focus on countering generic competition and preserving pharmaceutical brand revenue.

Much has been made about the slew of drugs that face the loss of patent protection in 2011. In all, experts estimate that $30 billion in branded drug revenue could dwindle away due to pharmaceutical generics competition in the next few years. Blockbuster brands like Pfizer’s Lipitor, Lilly’s Zyprexa, AstraZeneca’s Seroquel and Ortho McNeil’s Levaquin all have U.S. patents expiring in 2011. Continue reading


The Power of Line-Extension Tactics in Your Counter-Generics Strategy

Key Finding #4 from our Counter-Generics and Biosimilar Threats research:

Short-term strategies are still the most popular, but line-extension tactics gaining favor.

Over the past three years, short-term strategies, including litigation and defensive pricing, have led the way in popularity. Responding companies used each tactic 60% and 57%, respectively. Neither tactic requires very long to move from planning to completion. A large majority Continue reading