Merck KGaA to Further Biosimilar Investment

Merck KGaA announced plans today keeping the group on track for its “Fit for 2018” plan for growth and transformation.  Part of those plans include an additional $165 - $190 million investment in biosimilars for 2015.  Ultimately, that exact number is dependent on the outcome of certain Phase I trials that are currently ongoing.  That, of course, is in addition the $128 million the German company has set aside for biosimilars this year.

In addition, the company plans to expand on existing partnerships with India’s Dr. Reddy’s and Brazil’s Bionovis with an in-licensing agreement for a late-stage biosimilar.  Initially, the drug will be intended for smaller, emerging markets.  Between 2015 and 2016, Merck plans to initiate anywhere from two to five Phase III clinical trials. 

The release also noted some internal shuffle within Merck.  Stefan Oschmann has been promoted to deputy CEO and Vice Chairman of the executive board while Belén Garijo will move up to the executive board and head the pharma business. 

The full press release can be found here.

We’ll have more on the latest developments in the biosimilars market at the 15^thAnnual Business of Biosimilars meeting. Join us October 20-22 in Boston, MA. Download the agenda to see what’s on tap.

                                                                                                     

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Doctors Take Sides on Biosimilar Naming Issue

Doctors have officially taken sides in the naming rights battle for biosimilars.  In a recent letter to the FDA, a group of physicians has taken the stance that biologic and biosimilar drugs should in fact have unique names.  This letter comes weeks after another piece of mail showed up at the FDA headquarters requesting that the agency not require distinct names for the two types of drugs.  The lobbying is part of a struggle between biologics manufacturers who want to protect their brand equity by requiring separate names and potential biosimilar manufacturers wanting to piggy back off that equity by using the original drug names for their products.

The letter, signed by 23 different physicians, claims that no matter how similar drugs might be, they can cause different reactions among patients with similar diagnosis’ and physical traits.  Distinguishing between the drugs is key and the group feels similar names could get in the way of that.   

“A biosimilar will only be similar, but not identical to the reference product for the foreseeable future. Distinct nonproprietary names will help to alert physicians that each product, while safe and effective, may differ slightly,” the group writes to the FDA.  “Rather than deter physicians from prescribing these products, we believe that allowing physicians to know the exact product that they are prescribing will increase confidence, thus encouraging more robust utilization of biosimilars than may develop without this transparency.”

A recent survey found that in the Europe (where a robust biosimialr market already exists), 61% of physicians prescribing biologics or biosimilars were of the understanding that if two products shared an international non-proprietary name, they were approved for all of the same indications. 

Other lobbying efforts on this policy include a number of petitions submitted to the FDA over the last few weeks.  While the organization has been mum on a possible decision, the market may push their hand sooner rather than later.  Two drug makers are already seeking regulatory permission to sell certain medications meaning that at least one biosimilar could become available next year. 

Until then, the letters and petitions will likely continue to fill the mailboxes at the FDA’s headquarters.

Want more on the latest in the biosimilars industry? Join us for the 15th Annual Business of Biosimilars meeting, October 20-22 in Boston, MA.  Download the agenda to see what else is on tap.

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FDA Tentatively Approves Lilly's New Diabetes Medication

The FDA has granted Eli Lilly “tentative” approval for a diabetes medication akin to Sanofi’s Lantus.  The drug, to be marketed as Basaglar, is a long-lasting insulin injection that helps to control blood-sugar levels and is essentially a knockoff of the Sanofi version.

The new medication, however, won’t reach shelves for at least 30 months as Sanofi has filed a suit claiming patent infringement.  The drug could hit the market earlier if the court rules in favor of Eli Lilly but is in a holding pattern until then.  Lantus is scheduled to come off of patent February of next year.  This news comes months after Merck divulged plans to develop its own knockoff of the diabetes medication. 

Basaglar has the same amino acid sequence as Sanofi’s drug but for technical reasons is not considered a biosimilar—although for all intents and purposes, it is one.  By European standards, the drug does actually fall under the biosimilar classification and goes by the name Abasria.    

Said Christophe Arbet-Engels, Vice President, Metabolic-clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., "Because of the combined diabetes, development and commercialization experience of Lilly and Boehringer Ingelheim, we are confident that Basaglar, upon final approval, will become a valuable treatment choice for people who need a basal insulin to manage their type 1 or type 2 diabetes."

The biosimilars news is going to keep coming. We’ll have the breakdown of the latest industry updates and trends at the Business of Biosimilars conference. Join us October 20-22 in Boston, MA. Download the agenda here to see what’s on tap.

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