Eye on Pharma: Alternatives to Blockbuster Ophthalmology, Diabetes Meds Progress

Patients with ophthalmic conditions and diabetes may soon have greater access to some new treatment options, with the launch of Sandoz’ generic ocular hypertension therapy, a new deal to bring a ranibizumab biosimilar to the Middle East, and the initiation of a trial for an insulin glargine biosimilar.

Sandoz Launches Generic Combigan for Ocular Hypertension

Sandoz announced that it launched its generic combination eyedrop solution referencing Combigan on the US market. The solution contains 0.2% brimonidine tartrate and 0.5% timolol maleate solution and functions by lowering eye pressure in patients with ocular hypertension. The prescription eyedrop is now available to patients through retail pharmacies.

People can develop ocular hypertension, or high eye pressure, and patients who are African American or Hispanic, over 40 years old, have diabetes or high blood pressure, are near-sighted, or take long-term steroid medicines are at a higher risk for developing it. If left untreated, high eye pressure can lead to optic nerve damage and vision loss.

“Fixed combinations of medicines to treat ocular hypertension can offer patients enhanced convenience, improved adherence, reduced exposure to preservatives, and cost savings….We developed this important generic eye treatment in-house to expand patient access to high-quality, more affordable eye care for millions of US patients,” said Keren Haruvi, president of Sandoz, in a company statement.

Intas and Axantia Sign Deal for Ranibizumab Biosimilar in the Middle East

India-based Intas Pharmaceutical has teamed up with Axantia Holding for an exclusive license agreement, giving Axantia the commercialization rights of Intas’ ranibizumab biosimilar referencing of Lucentis.

Ranibizumab is used to treat wet age-related macular degeneration. It can also treat macular edema caused by a blocked blood vessel or diabetes, and diabetic retinopathy

Axantia will commercialize the drug through its pharmaceutical subsidiaries, Pharma International Pharmaceutical & Chemical Manufacturing and Med City Pharmaceutical Industries. Axantia will be responsible for registration for marketing authorization and commercialization in certain territories, such as Saudi Arabia, Jordan, Iraq, Lebanon, and countries within the Gulf Cooperation Council, which includes Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates.

The biosimilar candidate is currently being tested in phase 3 global clinical trials and Intas plans to submit for approval in the European Union and the United States.

Lannett Starts Pivotal Trail for Insulin Glargine Biosimilar

Lannett Company announced the start of a pivotal clinical trial of an insulin glargine biosimilar referencing Lantus. The biosimilar candidate was developed a part of Lannett's strategic alliance partnership within the HEC Group of companies.

“Biosimilar insulin glargine is by far the biggest and most important opportunity in our pipeline, and initiating the pivotal clinical trial is a major step forward in bringing a high quality, more affordable insulin to the millions of patients in the U.S. with diabetes,” said Tim Crew, CEO of Lannett, in a statement.

Crew said that results from the study should be available towards the end of 2022. If the results are successful, the company will be filing with the FDA for regulatory approval in early 2023 for a potential launch in the first half of 2024.

“We are optimistic of a successful outcome for the pivotal study,” Crew noted. "A new biosimilar insulin glargine from Lannett/HEC would be good and welcome news to those with diabetes, particularly those patients struggling with the cost of their insulin regimens."