Biogenerics

Small biotech campaigns for biogenerics law

John Carroll — Thu, 14 Aug 2008 11:12:09 -0400

The small biotech Insmed has been lobbying for new legislation that would clear a regulatory pathway for biosimilars. The Richmond, VA-based company wants to develop a portfolio of follow-ons and CEO Geoffrey Allan has been patiently educating lawmakers on the intricacies of biologics and how biosimilars could be made safely and inexpensively. Insmed has already mounted a small trial for its version of Amgen's Neupogen, which is on just about everyone's list of biologics most likely to face competition first.

Of course, Insmed's argument is diametrically opposed to the Biotechnology Industry Organization's, which has been campaigning for years to make sure any biosimilar law would require extensive trials after a prolonged period of exclusivity.

- read the report in the Washington Post

Live from BIO: For Biotechs, a bright future with challenges

Maureen Martino — Tue, 17 Jun 2008 18:21:42 -0400

At the first day of BIO 2008 conference I met with Murry Aitken, Senior VP of Healthcare Insight at IMS Health. IMS just released a report on the growth of biologic drugs in 2007. Global biologic sales increased 12.5 percent in 2007 to more than $75 billion; that's twice as fast as the pharmaceutical market, which increased 6.4 percent in 2007.

That's all good, from biotech's perspective, but Aitken says the industry is facing some big challenges in the years ahead. The most obvious eventual challenge for biologics are biosimilars--generic versions of biotech drugs. Europe has seven biosimilars on the market and while there is no clear pathway for approval in the U.S., that won't be the case forever. The good news for biotech is that the current impact of these drugs on their market share is minimal. The bad news is that the wild days of unlimited exclusivity for blockbuster drugs is coming to a close. The end is in sight. Within the next five to ten years, biotechs may be facing the problem that their cousins in pharma are struggling with now: generic competition.

More immediately, though, biotechs must address issues of safety versus costs. According to the IMS report, sales of erythropoietins (anemia drugs such as Epogen, Aranesp and Procrit) dropped nine percent last year due to safety concerns. At the same time, sales for all of the other top 10 biologic drug classes grew, many of them significantly. Medicare--which accounts for a huge chunk of erythropoietin sales--restricted payments for the Amgen and J&J drugs. It goes to show just how big an impact safety issues can have on even the best-selling

The FDA will be looking more closely for safety problems like those associated with erythropoietins. This year the FDA partnered with Medicare, Medicaid and private insurers to roll out the Sentinel project. Rather than waiting for doctors and patients to voluntarily report possible safety problems, the agency could actively monitor prescription drug use and its effects on people.

Biotechs in particular have to tread lightly in this new system. Biologics carry some safety risks, and almost as importantly, they can be very, very expensive. Insurers aren't too thrilled about picking up the tab, and would be even less likely to do so if more risks are found to be associated with pricey biologics. The sales hit erythropoietins took should serve as a warning. Aitken stressed that companies must be proactive, not reactive when dealing with safety information.

IMS's message is clear: Now is the time for biotech to prepare for the future. Over the last several years we've all watched as some of the industry biggest names have faltered under the crush of generic competition and weak pipelines. By keeping an eye on the future, biotech companies have the opportunity to prepare for challenges ahead and avoid many of the painful lessons pharma is learning now.

Biotech's next big opportunity: Follow-ons?

Thu, 24 Apr 2008 06:59:56 -0400

Follow-on biologics are often cited as major long-term threat to the biotech industry, which so far has not had to face a future where generic therapies are allowed to slice and dice the market for approved therapies. But new analysis from the RPM Report notes that biotech companies--along with the Big Pharma companies--may be much better positioned than generic drug developers to capitalize on the market.

The rationale is that developing follow-on proteins will demand exactly the kind of expertise that the biotech industry has on staff. Teva, meanwhile, has been on a buying spree and may be the only big generic developer that can compete in this space. Of course, before anyone produces follow-ons in the U.S. market, lawmakers have to agree on new legislation. And some proposals are calling for lengthy periods of exclusivity for biologics.

- read the analysis in the RPM Report

Genzyme gets biosimilar rejection, builds R&D plant

Tue, 22 Apr 2008 06:59:58 -0400

The FDA have given a thumbs down to Genzyme's request for permission to sell its Pompe disease drug Myozyme manufactured in an Allston, MA plant. Genzyme is already manufacturing the drug in a smaller Framingham-based plant and wants to ramp up production at the larger Allston location. But the FDA ruled that the Allston-produced Myozyme must "be classified as [a different product] because of differences in the carbohydrate structures of the molecules." The FDA said Genzyme has to submit a separate BLA to gain approval for Myozyme produced on a larger scale.

This rejection underscores the difficulty biosimilars face in the United States. "The FDA decision...suggests that regulators may be reluctant to approve any generic versions of biologic drugs...without clinical data proving the drugs are at least as safe and effective as the originals if there are even slight differences in the compounds," observes the Boston Globe. Currently, the U.S. has no pathway to quickly approve biosimilar drugs.

As Genzyme points out, Myozyme production has already been scaled up in 40 other countries. "Based on the global clinical experience of nearly 900 patients of all ages currently receiving Myozyme produced at the larger scale...Genzyme believes that Myozyme produced at both the 160L and 2000L scales is clinically effective and safe," the company said in a statement. The company expects the FDA to act on the application by the end of the year.

- see this release from Genzyme
- read the Boston Globe article

ALSO: Genzyme is opening a major new R&D center in Beijing. The facility will house 350 employees and will cost an estimated $90 million. Researchers in the Beijing plant will develop drugs in four focused areas: orthopedics, transplant and immune disease, oncology, endocrinology and cardiovascular disease. According the the release, the R&D facility "is part of Genzyme's ongoing global expansion and commitment to establishing a long-term presence in China." Report

Canadian regulators forging new biosimilar pathway

Tue, 25 Mar 2008 07:59:55 -0400

While U.S. lawmakers jawbone about a regulatory pathway for biosimilars, or biogenerics, Canada has moved to do it. Health Canada has posted draft guidelines for its regulatory approach to biosimilars. Manufacturers would have to show their products were similar to an existing biologic with interchangeability and substitutability decided on a case-by-case basis. New guidances are being drafted for various product classes.

In the U.S., meanwhile, there have been growing signs that any new legislation on biosimilars could be delayed past the current election year. But in Europe, regulators are busily approving a new slate of follow-on therapeutics.

- check out the report from FDA News
- read the article on the EMEA's approvals in Motley Fool

Related Articles:
Debate over follow-ons focus on market exclusivity. Report
Budget has mandate for biogeneric approvals. Report
Insulin debate spurs push for generic biologics. Report
Waiting game continues for biogenerics. Report

Debate over follow-ons focus on market exclusivity

Mon, 03 Mar 2008 06:59:54 -0500

The Boston Globe weighs in with a lengthy look at the tussle over biogenerics--a.k.a. follow-ons and biosimilars. The smart money is betting that at some point in the not-too-distant future Congress will get around to giving the FDA authority to approve biogenerics on a case-by-case basis. But don't expect the biotech lobbyists to back off of this issue anytime soon. As a concession, BIO is seeking 14-year market exclusivity for biotech drugs to compensate developers for the time it takes to gain approvals for these complex therapies. And they may come close: Lawmakers including Massachusetts' Ted Kennedy are backing a 12-year period of exclusivity.

- read the article in the Boston Globe

Related Articles:
Budget has mandate for biogeneric approvals. Report
Waiting game continues for biogenerics. Report
Dr. Reddy's make risky biogenerics move. Report
Lawmakers propose pathway for approving biosimilars. Report

The 2008 Election: What does it mean for drugmakers?

Maureen Martino — Wed, 06 Feb 2008 09:02:01 -0500

The winner of the 2008 election will be faced with making key decisions on a number of issues important to drug developers. Questions as to whether there will be more federal funding for stem cell research, a faster path for biogenerics, or a change to the structure of the nation’s healthcare system will have to be addressed by the next president, and how they tackle those issues will have serious repercussions for the industry. Here’s a look at the front-runners’ stance on several topics vital to the biotech and pharmaceutical industries.

Barack Obama supports:

Reimportation of drugs
Greater generic drug use by Medicare, Medicade, ect
Establishing a government institute for comparative research between drugs.
Allowing the government to purchase prescription drugs in bulk to reduce costs.
Universal healthcare
Embryonic stem cell (ESC) research

Hilary Clintion supports:

Doubling NCI and NHC funding
Increaseing the number of patients involved in cancer clinical trials.
A pathway for biogenerics
Lower prescription drug costs and universal health care
Giving Medicare the power to negotiate prescription drug prices
Stricter control of drug advertising
ESC research

John McCain supports:

A pathway to approve biogenerics
An increase use of generic drugs
Reimportation of drugs
Allowing the government to negotiate lower prices for prescription drugs for the Medicare Part D program
ESC research

- see this Motley Fool article for more

SPOTLIGHT: Election 2008: What does it mean for drugmakers?

Wed, 06 Feb 2008 06:59:53 -0500

The winner of the 2008 election will be faced with making key decisions on a number of issues important to drug developers. Questions as to whether there will be more federal funding for stem cell research, a faster path for biogenerics, or a change to the structure of the nation's healthcare system will have to be addressed by the next president, and how they tackle those issues will have serious repercussions for the industry. Here's a look at the four front-runners' stance on several topics vital to the biotech and pharmaceutical industries. Report

In new approach, R&D units are spun off

Thu, 25 Oct 2007 06:59:56 -0400

In the old model for drug discovery, R&D is needed to provide a regular crop of new drug prospects to replace the therapies coming off patent. But that's not so in the generics world. Some of India's top generics companies are spinning off their R&D operations into separate companies. Ranbaxy Laboratories and Dr. Reddy's say that these spinoffs make more sense.

- read the report from the Financial Times

Related Articles:
Ranbaxy spins off R&D unit. Report
Ranbaxy touts R&D abilities in new discovery pact. Report
Dr. Reddy's make risky biogenerics move. Report

SPOTLIGHT: India focuses on biosimilars

Tue, 25 Sep 2007 06:59:53 -0400

India sees a big future for itself in biogenerics. Wockhardt, Dr Reddy's Lab, Biocon, Sun Pharma, Shanta Biotech, Panacea Biotech and Ranbaxy Lab are all initiating programs to develop biosimilars in anticipating of U.S. approval of a new regulatory pathway--at some point. Exactly what that point is, though, remains a mystery. Report

Pfizer's future rests with biotech

Maureen Martino — Thu, 13 Sep 2007 11:00:07 -0400

At this week’s Bear Stearns Healthcare Conference, Pfizer discussed its plans for the future with analysts. As we all know, Pfizer is facing a major loss of sales when its best-selling drug Lipitor goes off patent in 2010. This wasn’t a major cause for concern until January, when Pfizer abandoned development of Torcetrapib due to concerns about mortality and cardiovascular events. Torcetrapib was slated to replace Lipitor, and the stunning loss of the progam left a gaping hole in Pfizer’s pipeline. In addition to concerns about Lipitor, both Viagra and Geodon, a schizophrenia therapy, will be faced with generic competitors by 2014. All told, Pfizer has to find a way to replace an annual $19 billion in sales when these drugs go off patent.

So how is Pfizer planning to deal with this loss? Company officials told analysts that Pfizer would increase its focus on biologics, which are much more difficult to make generic copies of. Lawmakers and healthcare professionals both here and abroad have embraced generic pharmaceuticals, which are relatively easy for generic drugmakers to produce. But Congress and the FDA have been slow to greenlight a faster approval process for generic biologics (on the other hand, the EMEA has had a regulatory pathway in place for almost three years). Pfizer has already announced a plan to invest $10 million a year for the next five years to help start-up biotechs in San Diego. Expect to see Pfizer snapping up biologics from smaller drug developers and investing more money in biotech companies in the months and years to come.

- read the Motley Fool article for more

Related Articles:
Pfizer goes public with R&D pipeline. Report
Troubled Pfizer blueprints biotech venture effort. Report
Waiting game continues for biogenerics. Report
Democrats to push for generic biotech drugs. Report
Pfizer halts Torcetrapib development. Report
Wal-Mart expands $4 drug program, Target follows. Report
Biotech sees big money from corporate players. Report

Waiting game continues for biogenerics

Mon, 10 Sep 2007 06:59:59 -0400

The folks at BIO are breathing a sigh of relief over Congressman Henry Waxman's comment that new legislation on biosimilars was unlikely to reach the House floor this week. He chalked the delay up to scheduling issues. Of course, with the Democrats in charge of the House and Senate, one wonders why a piece of legislation like this can't go ahead swiftly. It's more than apparent that lawmakers are willing to create a regulatory pathway for generic versions of biotech drugs. And they'll more than likely follow the FDA's position that each of these biogeneric--or biosimilar--applications should be reviewed on a case-by-case basis. Where regulators see complexity in a biologic, they will raise the bar on data. Where a therapy can be copied without raising serious safety issues, which is now done routinely, it will be approved without a terribly demanding set of trials.

All of that is clear enough. So why the delay? I suspect lawmakers are just finding it tough to get their act together. That's one good reason for the growing level of public frustration at lawmakers of every stripe. PDUFA legislation will go ahead because it has to. The FDA needs the money to operate. Meanwhile, the demand for less expensive biologics will only grow. Does anyone in Washington know how this game is played? - John Carroll