Pharmaceutical lifecycle management strategies have changed in the past decades. In the old days of industry lore, companies could roadblock generic market intrusion by conducting clandestine laboratory tests and sending letters to FDA pointing out flaws in the generic’s bioequivalence – just to list one colorful example. But those days are past. Today, pharma companies will have better success countering generics with strategic pricing techniques.
Generics often toll the death knell for branded drugs because of their low price. Since companies can’t beat generic prices, they might as well join them by lowering the price or offering rebates of their branded drugs at the entrance of generics. A recent study by Cutting Edge Information found that 40% of surveyed companies with strategic pricing utilized these strategies to slow market share decline after exclusivity loss (Figure 1). Continue reading
After being untouchable for decades, US biologics companies are finally facing biosimilar competition. Well, sort of. Cutting Edge Information’s report on counter-generics strategies found that the high cost of biosimilar production will not allow companies to price biosimilars substantially below that of the original product – meaning they may not have the same market impact that a typical generic would. Instead, biobetters may be the next biggest thing to rock the biologics world. Continue reading
Ending product patents and generic competition are very real challenges in the pharmaceutical landscape. With limited counter-generics strategies, partnerships with generics companies can be an effective solution for organizations looking to maximize lifetime revenue for their branded products. While these tactics can have great returns, they do require a high-level of investment and foresight—making them difficult to execute. Continue reading
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 Enbrel (etanercept) – one of Amgen’s biggest sellers. 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
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, generics companies were on notice that they must be cautious in attempting aggressive generics launches. Continue reading
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. Counter generics start early: companies should 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
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
After years of nurturing its global blockbuster and trying to prepare for patent expiration, Pfizer’s Lipitor is finally open to direct generic competition in the United States. Ranbaxy, which has 180 days of exclusivity on the market due to a settlement with Pfizer, recently launched its generic atorvastatin. During this period, the only other atorvastatin products on the market will be branded Lipitor and an offering from Watson Pharmaceuticals, which is selling an authorized generic version on behalf of Pfizer. Continue reading
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
This is the third installment in a blog series focusing on pharmaceutical brand defense strategies. You can read part 1 about the patent cliff and the second part on patent litigation.
Under the FDA’s Modernization Act, pharmaceutical brands are granted an additional six-month marketing exclusivity period in exchange for detailed pediatric data. The prolonged exclusivity period designates the brand manufacturer as the sole supplier and prevents any generic competitors from reaching the market. Even more interesting is that the pediatric data does not have to reveal positive efficacy to be granted pediatric exclusivity. Simply conducting the agreed upon pediatric focused trials will earn a brand the additional six months exclusivity. Continue reading