As the FDA considers whether it should approve recently filed biosimilar versions of Johnson & Johnson's ($JNJ) Remicade and Amgen's ($AMGN) Neupogen, a parade of pharma companies, physicians and payers is coming forward to voice their concerns, not the least of which is how these products will be named. Now another group of concerned parties has joined the chorus: investors.
A group of 19 institutional investors wrote to the boards of several major pharma and biotech companies, asking them to agree to various business principles that would support the use of biosimilars, according to The Wall Street Journal blog Pharmalot. If life sciences stakeholders continue to bicker over biosim drugs, the investors say, they will undermine shareholder value and limit any potential savings the healthcare system can generate by embracing them.
"We're asking the boards for rules of engagement in the policy arena because we're concerned these activities are not aligned with investor interests," Meredith Miller, chief governance officer at the UAW Retiree Medical Benefits Trust, told the WSJ. Miller's group spearheaded the effort to assemble the group of concerned pharma investors, which includes the Illinois State Board of Investment, the AFL-CIO Office of Investment and the New York Common Retirement Fund. The investors manage about $430 billion in combined assets, according to the WSJ.
One of the concerns the investors cite is that some pharma companies have been badmouthing the safety of biosimilars, even though they already have a well-established track record in Europe. "Companies seeking to downplay the patient safety record of European biosimilars have also challenged the capacity of the FDA to promulgate rules and determine when biosimilars may be substituted for biologics," the letter says.
In other words, if biopharma execs don't have something nice to say about biosimilars, they should just shut up.
The investors are also worried about the naming debate. Late last week, several medical associations and individual physicians signed a letter to FDA Commissioner Margaret Hamburg stating that biosimilars should have unique names--a position the pharma companies support.
But the UAW and its co-signers disagree, stating in their letter that it would be a mistake to give biosimilars different names from the products they emulate. "In our view, assigning different names communicates to providers that the biosimilar is less effective, causing providers not to prescribe it and ultimately making it difficult for pharmacists to dispense," they say. Pharmacy benefits managers have also voiced support for uniform naming policies.
In concluding their letter, the investors asked specifically for pharma companies to agree that all educational materials about biosimilars will be fair and accurate and all lobbying expenses related to them will be disclosed. They are also requesting more transparency in business deals that may resemble the infamous "pay-for-delay" partnerships that have been formed between pharmaceutical companies and makers of small-molecule generic drugs. In March, the Federal Trade Commission got so fed up with such partnerships that its director, Deborah Feinstein, vowed to collect at least one billion-dollar settlement in a pharma antitrust case this year.
The letter points out that the rules laid out in the Hatch-Waxman Act for disclosing pay-for-delay deals to the FTC don't apply to biosimilars. "Investors fear that without full disclosure of the value, terms and duration of these arrangements, investors and analysts will not be able to evaluate the risks associated with the transactions," it states.
Only Amgen and Novartis ($NVS) have agreed to sign the proposed business principles, while Roche's ($RHHBY) Genentech has declined to participate, according to the WSJ blog. The UAW's Miller says they're still waiting to hear from the other pharma and biotech companies that received the request. "We will be watching the companies and hold them accountable," she says.